[Federal Register Volume 82, Number 48 (Tuesday, March 14, 2017)]
[Notices]
[Pages 13609-13632]
[FR Doc No: 2017-04938]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-1129]

Medical Devices; Exemptions From Premarket Notification: Class II
Devices; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or Agency) has
identified a list of class II devices that, when finalized, will be
exempt from premarket notification requirements, subject to certain
limitations. FDA is publishing this notice of that determination and
requesting public comment in accordance with procedures established by
the 21st

Century Cures Act. This notice does not represent FDA's final
determination with respect to the class II devices included in this
document. FDA will review any comments submitted within the 60-day
comment period and will consider whether the list of class II devices
should be modified prior to publication of its final determination in
the Federal Register.

DATES: Submit either electronic or written comments on the notice by
May 15, 2017. Late, untimely filed comments will not be considered.
Electronic comments must be submitted on or before May 15, 2017. The
https://www.regulations.gov electronic filing system will accept
comments until midnight Eastern Time at the end of May 15, 2017.
Comments received by mail/hand delivery/courier (for written/paper
submissions) will be considered timely if they are postmarked or the
delivery service acceptance receipt is on or before that date.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-N-1129 for ``Medical Devices; Exemptions from Premarket
Notification: Class II Devices.'' Received comments, those filed in a
timely manner (see DATES), will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Bryce Bennett, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5244, Silver Spring, MD 20993,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Under section 513 of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 360c), FDA must classify devices into one of three
regulatory classes: Class I, class II, or class III. FDA classification
of a device is determined by the amount of regulation necessary to
provide a reasonable assurance of safety and effectiveness. Under the
Medical Device Amendments of 1976 (1976 amendments) (Pub. L. 94-295),
and the amendments of the Safe Medical Devices Act of 1990 (Pub. L.
101-629), devices are to be classified into class I (general controls)
if there is information showing that the general controls of the FD&C
Act are sufficient to assure safety and effectiveness; into class II
(special controls), if general controls, by themselves, are
insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls to provide such assurance; and into class III (premarket
approval), if there is insufficient information to support classifying
a device into class I or class II and the device is a life sustaining
or life supporting device or is for a use which is of substantial
importance in preventing impairment of human health or presents a
potential unreasonable risk of illness or injury.
    Most generic types of devices that were on the market before the
date of the 1976 amendments (May 28, 1976) (generally referred to as
preamendments devices) have been classified by FDA under the procedures
set forth in section 513(c) and (d) of the FD&C Act through the
issuance of classification regulations into one of these three
regulatory classes. Devices introduced into interstate commerce for the
first time on or after May 28, 1976 (generally referred to as
postamendments devices) are classified through the premarket
notification process under section 510(k) of the FD&C Act (21 U.S.C.
360(k)). Section 510(k) of the FD&C Act and the implementing
regulations, part 807 of Title 21 of the Code of Federal Regulations
(CFR), require persons who intend to market a new device to submit a
premarket notification (510(k))

containing information that allows FDA to determine whether the new
device is ``substantially equivalent'' within the meaning of section
513(i) of the FD&C Act to a legally marketed device that does not
require premarket approval.
    On December 13, 2016, the President signed into law the 21st
Century Cures Act (Pub. L. 114-255). Section 3054 of the 21st Century
Cures Act amended section 510(m) of the FD&C Act. As amended, section
510(m)(1)(A) of the FD&C Act requires FDA to publish in the Federal
Register a notice containing a list of each type of class II device
that FDA determines no longer requires a report under section 510(k) of
the FD&C Act to provide reasonable assurance of safety and
effectiveness. FDA is required to publish this notice within 90 days of
the date of enactment of the 21st Century Cures Act and at least once
every 5 years thereafter, as FDA determines appropriate. Additionally,
FDA must provide at least a 60-day comment period for any such notice
required to be published under section 510(m)(1)(A) of the FD&C Act.
Within 210 days of enactment of the 21st Century Cures Act, FDA must
publish in the Federal Register a list representing its final
determination regarding the exemption of the devices that were
contained in the present list published under section 510(m)(1)(A) of
the FD&C Act. Section 510(m)(3) of the FD&C Act provides that upon the
date of publication of the final list in the Federal Register, a 510(k)
will no longer be required for these devices and the classification
regulation applicable to each such type of device shall be deemed
amended to incorporate such exemption.
    In a final action, and after considering comments, FDA intends to
amend the codified language for each listed regulation to reflect the
final determination with respect to exempt devices. FDA's final action
will decrease regulatory burdens on the medical device industry and
will eliminate private costs and expenditures required to comply with
Federal regulation. Specifically, regulated industry will no longer
have to invest time and resources in 510(k) notifications, including
preparation of documents and data for submission to FDA, payment of
user fees associated with 510(k) submissions, and responding to
questions and requests for additional information from FDA during
510(k) review.

II. Criteria for Exemption

    There are a number of factors FDA may consider to determine whether
a 510(k) is necessary to provide reasonable assurance of the safety and
effectiveness of a class II device. These factors are discussed in the
guidance the Agency issued on February 19, 1998, entitled ``Procedures
for Class II Device Exemptions from Premarket Notification, Guidance
for Industry and CDRH Staff'' (Ref. 1).

III. Limitations on Exemptions

    FDA believes that the types of class II devices listed in this
notice should be exempt from the premarket notification requirements
found under section 510(k) of the FD&C Act. However, an exemption from
the requirement of premarket notification does not mean that the device
is exempt from any other statutory or regulatory requirements, unless
such exemption is explicitly provided by order or regulation. FDA's
initial determination that premarket notification is unnecessary to
provide a reasonable assurance of safety and effectiveness for devices
listed in this document is based, in part, on the assurance of safety
and effectiveness that other regulatory controls, such as current good
manufacturing practice requirements, provide.
    In addition to being subject to the general limitations to the
exemptions found in Sec. Sec.  862.9 to 892.9) 21 CFR 862.9 to 892.9,
FDA may partially limit the exemption from premarket notification
requirements to specific devices within a listed device type. In table
1, for example, FDA is listing the exemption of the endoscopic magnetic
retriever, but limits the exemption to such devices that are for single
use. All other endoscopic magnetic retrievers are still subject to
premarket notification requirements because FDA determined that
premarket notification is necessary to provide a reasonable assurance
of safety and effectiveness for these devices.

IV. List of Class II Devices

    FDA is identifying the following list of class II devices that, if
finalized, would no longer require premarket notification under section
510(k) of the FD&C Act, subject to the general limitations to the
exemptions found in Sec. Sec.  862.9 to 892.9:

                        Table 1--Class II Devices
------------------------------------------------------------------------
                                                      Partial exemption
    21 CFR section       Device type      Product      limitation (if
                                           code          applicable)
------------------------------------------------------------------------
862.1020.............  Acid             CJN         ....................
                        Phosphatase,
                        Nitrophenylpho
                        sphate.
862.1020.............  Acid             CJR         ....................
                        Phosphatase,
                        Thymol Blue
                        Monophosphate.
862.1020.............  Acid             CJX         ....................
                        Phosphatase,
                        Disodium
                        Phenylphosphat
                        e.
862.1020.............  Acid             CKB         ....................
                        Phosphatase,
                        Naphthyl
                        Phosphate.
862.1020.............  Acid             CKE         ....................
                        Phosphatase,
                        Thymolphthale
                        Inmonophosphat
                        e.
862.1020.............  Acid             CKH         ....................
                        Phosphatase,
                        Beta
                        Glycerophospha
                        te.
862.1020.............  Acid             JFH         ....................
                        Phosphatase
                        (Prostatic),
                        Tartrate
                        Inhibited.
862.1090.............  Radioassay,      KQN         ....................
                        Angiotensin
                        Converting
                        Enzyme.
862.1100.............  Vanillin         CIF         ....................
                        Pyruvate, AST/
                        SGOT.
862.1100.............  Diazo, AST/SGOT  CIQ         ....................
862.1100.............  Hydrazone        CIS         ....................
                        Colorimetry,
                        AST/SGOT.
862.1100.............  NADH Oxidation/  CIT         ....................
                        NAD Reduction,
                        AST/SGOT.
862.1150.............  Calibrator,      JIS         ....................
                        Primary.
862.1150.............  Calibrator,      JIT         ....................
                        Secondary.

862.1150.............  Calibrator,      JIW         ....................
                        Surrogate.
862.1150.............  Calibrator,      JIX         ....................
                        Multi-Analyte
                        Mixture.
862.1345.............  Drink, Glucose   MRV         ....................
                        Tolerance.
862.1350.............  Continuous       PJT         ....................
                        Glucose
                        Monitor
                        Secondary
                        Display.
862.1445.............  Chromatographic  CEX         ....................
                        Separation,
                        Lactate
                        Dehydrogenase
                        Isoenzymes.
862.1445.............  Electrophoretic  CFE         ....................
                        , Lactate
                        Dehydrogenase
                        Isoenzymes.
862.1445.............  Differential     JGF         ....................
                        Rate Kinetic
                        Method,
                        Lactate
                        Dehydrogenase
                        Isoenzymes.
862.1509.............  System, Test,    LPT         ....................
                        Urinary
                        Methylmalonic
                        Acid.
862.1685.............  Radioimmunoassa  CEE         ....................
                        y, Thyroxine-
                        Binding
                        Globulin.
862.1700.............  Radioimmunoassa  CDX         ....................
                        y, Total
                        Thyroxine.
862.1700.............  Enzyme           KLI         ....................
                        Immunoassay,
                        Non-
                        Radiolabeled,
                        Total
                        Thyroxine.
862.2265.............  High Throughput  PFF         ....................
                        DNA Sequence
                        Analyzer.
862.2570.............  Instrumentation  NSU         ....................
                        For Clinical
                        Multiplex Test
                        Systems.
862.2570.............  Real Time        OOI         ....................
                        Nucleic Acid
                        Amplification
                        System.
862.2570.............  Mass             OTA         ....................
                        Spectrometer
                        For Clinical
                        Multiplex Test
                        Systems.
862.2570.............  Micro Total      OUE         ....................
                        Analysis
                        Instrument
                        System.
862.2570.............  Complete Gene    OVA         ....................
                        Expression
                        Profiling
                        Accessory
                        Reagents.
862.2570.............  DNA Genetic      PCA         ....................
                        Analyzer.
862.2570.............  Data             PQQ         ....................
                        Acquisition
                        Software.
862.3100.............  Enzyme           DKZ         Exemption is limited
                        Immunoassay,                 to test systems
                        Amphetamine.                 intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3100.............  Radioimmunoassa  DJP         Exemption is limited
                        y, Amphetamine.              to test systems
                                                     intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3100.............  Thin Layer       DIT         Exemption is limited
                        Chromatography               to test systems
                        , Amphetamine.               intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3100.............  Gas              DOD         Exemption is limited
                        Chromatography               to test systems
                        , Amphetamine.               intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3100.............  Liquid           DNI         Exemption is limited
                        Chromatography               to test systems
                        , Amphetamine.               intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3150.............  Enzyme           DJL         Exemption is limited
                        Immunoassay,                 to test systems
                        Barbiturate.                 intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3150.............  Enzyme           DIS         Exemption is limited
                        Immunoassay,                 to test systems
                        Barbiturate.                 intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).

862.3150.............  Radioimmunoassa  DKN         Exemption is limited
                        y, Barbiturate.              to test systems
                                                     intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3150.............  Thin Layer       DKX         Exemption is limited
                        Chromatography               to test systems
                        , Barbiturate.               intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3150.............  Mercury          DJN         Exemption is limited
                        Dithiazone,                  to test systems
                        Colorimetry,                 intended for
                        Barbiturate.                 employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3150.............  Hemagglutinatio  DLX         Exemption is limited
                        n Inhibition,                to test systems
                        Barbiturate.                 intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3150.............  Gas Liquid       DMF         Exemption is limited
                        Chromatography               to test systems
                        , Barbiturate.               intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3150.............  High Pressure    KZY         Exemption is limited
                        Liquid                       to test systems
                        Chromatography               intended for
                        , Barbiturate.               employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3170.............  Enzyme           JXM         Exemption is limited
                        Immunoassay,                 to test systems
                        Benzodiazepine.              intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3170.............  High Pressure    LAA         Exemption is limited
                        Liquid                       to test systems
                        Chromatography               intended for
                        ,                            employment and
                        Benzodiazepine.              insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3170.............  Test,            NFV         Exemption is limited
                        Benzodiazepine               to test systems
                        , Over The                   intended for
                        Counter.                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3170.............  Gas              KZZ         Exemption is limited
                        Chromatography               to test systems
                        ,                            intended for
                        Benzodiazepine.              employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3170.............  Thin Layer       LAB         Exemption is limited
                        Chromatography               to test systems
                        ,                            intended for
                        Benzodiazepine.              employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3200.............  Calibrators,     DKB         ....................
                        Drug Mixture.
862.3200.............  Calibrators,     DLJ         ....................
                        Drug Specific.
862.3200.............  Calibrators,     DNN         ....................
                        Ethyl Alcohol.
862.3250.............  Enzyme           DIO         Exemption is limited
                        Immunoassay,                 to test systems
                        Cocaine and                  intended for
                        Cocaine                      employment and
                        Metabolites.                 insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3250.............  Radioimmunoassa  KLN         Exemption is limited
                        y, Cocaine                   to test systems
                        Metabolite.                  intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).

862.3250.............  Enzyme           JXO         Exemption is limited
                        Immunoassay,                 to test systems
                        Cocaine.                     intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3250.............  Hemagglutinatio  DLN         Exemption is limited
                        n, Cocaine                   to test systems
                        Metabolites                  intended for
                        (Benzoylecgoni               employment and
                        ne).                         insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3250.............  Thin Layer       DMN         Exemption is limited
                        Chromatography               to test systems
                        , Cocaine.                   intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3250.............  Free Radical     DIR         Exemption is limited
                        Assay, Cocaine.              to test systems
                                                     intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3250.............  Gas              DIN         Exemption is limited
                        Chromatography               to test systems
                        , Cocaine.                   intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3250.............  Thin Layer       DOM         Exemption is limited
                        Chromatography               to test systems
                        ,                            intended for
                        Benzoylecgonin               employment and
                        e.                           insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3250.............  High Pressure    LAC         Exemption is limited
                        Liquid                       to test systems
                        Chromatography               intended for
                        , Cocaine and                employment and
                        Cocaine                      insurance testing
                        Metabolites.                 and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3270.............  High Pressure    LAE         Exemption is limited
                        Liquid                       to test systems
                        Chromatography               intended for
                        , Codeine.                   employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3270.............  Thin Layer       DLD         Exemption is limited
                        Chromatography               to test systems
                        , Codeine.                   intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3270.............  Gas              LAD         Exemption is limited
                        Chromatography               to test systems
                        , Codeine.                   intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3580.............  Radioimmunoassa  DLB         Exemption is limited
                        y, LSD (125-I).              to test systems
                                                     intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3580.............  Free Radical     DOL         Exemption is limited
                        Assay, LSD.                  to test systems
                                                     intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3610.............  Gas              LAF         Exemption is limited
                        Chromatography               to test systems
                        ,                            intended for
                        Methamphetamin               employment and
                        e.                           insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3610.............  Thin Layer       DJC         Exemption is limited
                        Chromatography               to test systems
                        ,                            intended for
                        Methamphetamin               employment and
                        e.                           insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).

862.3610.............  High Pressure    LAG         Exemption is limited
                        Liquid                       to test systems
                        Chromatography               intended for
                        ,                            employment and
                        Methamphetamin               insurance testing
                        e.                           and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3610.............  Test,            NGG         Exemption is limited
                        Methamphetamin               to test systems
                        e, Over The                  intended for
                        Counter.                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3620.............  Enzyme           DJR         Exemption is limited
                        Immunoassay,                 to test systems
                        Methadone.                   intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3620.............  Hemagglutinatio  DIW         Exemption is limited
                        n Inhibition,                to test systems
                        Methadone.                   intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3620.............  Gas              DMB         Exemption is limited
                        Chromatography               to test systems
                        , Methadone.                 intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3620.............  Thin Layer       DKR         Exemption is limited
                        Chromatography               to test systems
                        , Methadone.                 intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3620.............  Liquid           DNT         Exemption is limited
                        Chromatography               to test systems
                        , Methadone.                 intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3620.............  Free Radical     DPP         Exemption is limited
                        Assay,                       to test systems
                        Methadone.                   intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3630.............  Radioimmunoassa  KXS         Exemption is limited
                        y,                           to test systems
                        Methaqualone.                intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3640.............  Thin Layer       DNK         Exemption is limited
                        Chromatography               to test systems
                        , Morphine.                  intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3640.............  Radioimmunoassa  DOE         Exemption is limited
                        y, Morphine                  to test systems
                        (123-I), Goat                intended for
                        Antibody                     employment and
                        Ammonium                     insurance testing
                        Sulfate Sep..                and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3640.............  Fluorometry,     DJJ         Exemption is limited
                        Morphine.                    to test systems
                                                     intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3640.............  Liquid           DPK         Exemption is limited
                        Chromatography               to test systems
                        , Morphine.                  intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3640.............  Gas              DMY         Exemption is limited
                        Chromatography               to test systems
                        , Morphine.                  intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).

862.3640.............  Hemagglutinatio  DLR         Exemption is limited
                        n Inhibition,                to test systems
                        Morphine.                    intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3640.............  Free Radical     DOK         Exemption is limited
                        Assay,                       to test systems
                        Morphine.                    intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3640.............  Radioimmunoassa  DIQ         Exemption is limited
                        y, Morphine (3-              to test systems
                        H), Goat                     intended for
                        Antibody                     employment and
                        Ammonium                     insurance testing
                        Sulfate Sep..                and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3640.............  Radioimmunoassa  DNA         Exemption is limited
                        y, Morphine-                 to test systems
                        Barbiturate                  intended for
                        (125-I), Goat                employment and
                        Antibody.                    insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3650.............  Enzyme           DJG         Exemption is limited
                        Immunoassay,                 to test systems
                        Opiates.                     intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3650.............  Gas              DJF         Exemption is limited
                        Chromatography               to test systems
                        , Opiates.                   intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3650.............  Hemagglutinatio  DLT         Exemption is limited
                        n, Opiates.                  to test systems
                                                     intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3650.............  Thin Layer       LAI         Exemption is limited
                        Chromatography               to test systems
                        , Opiates.                   intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3650.............  Free Radical     DKT         Exemption is limited
                        Assay, Opiates.              to test systems
                                                     intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3650.............  High Pressure    LAH         Exemption is limited
                        Liquid                       to test systems
                        Chromatography               intended for
                        , Opiates.                   employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3700.............  Enzyme           JXN         Exemption is limited
                        Immunoassay,                 to test systems
                        Propoxyphene.                intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3700.............  Thin Layer       DPN         Exemption is limited
                        Chromatography               to test systems
                        , Propoxyphene.              intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3700.............  Gas              LAJ         Exemption is limited
                        Chromatography               to test systems
                        , Propoxyphene.              intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3700.............  High Pressure    LAK         Exemption is limited
                        Liquid                       to test systems
                        Chromatography               intended for
                        , Propoxyphene.              employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).

862.3870.............  Enzyme           LDJ         Exemption is limited
                        Immunoassay,                 to test systems
                        Cannabinoids.                intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3870.............  Reagents, Test,  DKE         Exemption is limited
                        Tetrahydrocann               to test systems
                        abinol.                      intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3870.............  Radioimmunoassa  LAT         Exemption is limited
                        y,                           to test systems
                        Cannabinoid(S).              intended for
                                                     employment and
                                                     insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3910.............  High Pressure    LFI         Exemption is limited
                        Liquid                       to test systems
                        Chromatography               intended for
                        , Tricyclic                  employment and
                        Antidepressant               insurance testing
                        Drugs.                       and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3910.............  U.V.             LFH         Exemption is limited
                        Spectrometry,                to test systems
                        Tricyclic                    intended for
                        Antidepressant               employment and
                        Drugs.                       insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
862.3910.............  Thin Layer       MLK         Exemption is limited
                        Chromatography               to test systems
                        , Tricyclic                  intended for
                        Antidepressant               employment and
                        Drugs.                       insurance testing
                                                     and does not
                                                     include test
                                                     systems intended
                                                     for Federal drug
                                                     testing programs
                                                     (e.g., programs run
                                                     by the Substance
                                                     Abuse and Mental
                                                     Health Services
                                                     Administration
                                                     (SAMHSA), the
                                                     Department of
                                                     Transportation
                                                     (DOT), and the U.S.
                                                     military.).
864.5400.............  Fibrometer.....  GIE         ....................
864.5400.............  Timer,           JBT         ....................
                        Coagulation.
864.5425.............  Control,         GGC         ....................
                        Plasma,
                        Abnormal.
864.5425.............  Plasma,          GGN         ....................
                        Coagulation
                        Control.
864.5425.............  Plasma,          GIZ         ....................
                        Control,
                        Normal.
864.6550.............  Control, Fecal   OSL         ....................
                        Occult Blood.
864.6650.............  Study, Platelet  JBZ         ....................
                        Adhesive.
864.7275.............  Test,            JBO         ....................
                        Euglobulin
                        Lysis.
864.7300.............  Fibrin Monomer   JBN         ....................
                        Paracoagulatio
                        n.
864.7340.............  Fibrinogen       GFX         ....................
                        Standard.
864.7340.............  Plasma,          GIL         ....................
                        Fibrinogen
                        Control.
864.7375.............  Glutathione,     GII         ....................
                        Red-Cell.
864.7375.............  Fluorescence,    JMH         ....................
                        Visual
                        Observation
                        (Qual., U.V.),
                        Glutathione
                        Reductase.
864.7375.............  Assay,           KQF         ....................
                        Glutathione
                        Reductase.
864.7415.............  Control,         JCM         ....................
                        Hemoglobin,
                        Abnormal.
864.7455.............  Stain, Fetal     GHQ         ....................
                        Hemoglobin.
864.7500.............  Acid Hematin...  GGF         ....................
864.7720.............  Test,            GGQ         ....................
                        Prothrombin
                        Consumption.
864.7735.............  Prothrombin-     JPF         ....................
                        Proconvertin
                        and
                        Thrombotest.
864.8150.............  Calibrator for   KRX         ....................
                        Cell Indices.
864.8165.............  Calibrator for   KRZ         ....................
                        Hemoglobin and
                        Hematocrit
                        Measurement.
864.8175.............  Calibrator for   KRY         ....................
                        Platelet
                        Counting.
864.8185.............  Calibrator for   KSA         ....................
                        Red-Cell and
                        White-Cell
                        Counting.
864.8625.............  Standards and    GFS         ....................
                        Controls,
                        Hemoglobin,
                        Normal and
                        Abnormal.
864.8625.............  Control, White-  GGL         ....................
                        Cell.
864.8625.............  Control,         GGM         ....................
                        Hemoglobin.
864.8625.............  Control,         GJP         ....................
                        Platelet.
864.8625.............  Control, Red-    GJR         ....................
                        Cell.
864.8625.............  Control,         GLK         ....................
                        Hematocrit.
864.8625.............  Mixture,         GLQ         ....................
                        Control, White-
                        Cell and Red-
                        Cell Indices.
864.8625.............  Control, Cell    JCN         ....................
                        Counter,
                        Normal and
                        Abnormal.
864.8625.............  Mixture,         JPK         ....................
                        Hematology
                        Quality
                        Control.

864.8625.............  Material,        NRF         ....................
                        Quality
                        Control, Semen
                        Analysis.
864.8625.............  Control          NRS         ....................
                        Material,
                        Blood
                        Circulating
                        Epithelial
                        Cancer Cell.
864.9400.............  Solution,        KSK         ....................
                        Stabilized
                        Enzyme.
866.3395.............  Norovirus        OUC         ....................
                        Serological
                        Reagents.
866.5210.............  Immunochemical,  CHN         ....................
                        Ceruloplasmin.
866.5210.............  Ceruloplasmin,   DCT         ....................
                        Rhodamine,
                        Antigen,
                        Antiserum,
                        Control.
866.5210.............  Ceruloplasmin,   DCY         ....................
                        FITC, Antigen,
                        Antiserum,
                        Control.
866.5210.............  Ceruloplasmin,   DDB         ....................
                        Antigen,
                        Antiserum,
                        Control.
866.5210.............  P-Phenyl-        JFQ         ....................
                        Enediamine/
                        EDTA
                        (Spectrophotom
                        etric),
                        Ceruloplasmin.
866.5210.............  Indirect Copper  JFR         ....................
                        Assay,
                        Ceruloplasmin.
866.5470.............  Hemoglobin,      DAM         ....................
                        Chain
                        Specific,
                        Antigen,
                        Antiserum,
                        Control.
866.5620.............  Alpha-2-         DDT         ....................
                        Macroglobulin,
                        Rhodamine,
                        Antigen,
                        Antiserum,
                        Control.
866.5620.............  Alpha-2-         DDY         ....................
                        Macroglobulin,
                        FITC, Antigen,
                        Antiserum,
                        Control.
866.5620.............  Alpha-2-         DEB         ....................
                        Macroglobulin,
                        Antigen,
                        Antiserum,
                        Control.
866.5630.............  System, Test,    JZG         ....................
                        Beta-2-
                        Microglobulin
                        Immunological.
866.5750.............  System, Test,    DHB         Exemption is limited
                        Radioallergoso               to devices
                        rbent (RAST)                 classified under 21
                        Immunological.               CFR 866.5750 that
                                                     are intended to
                                                     detect any of the
                                                     allergens included
                                                     in table 2 of this
                                                     document.
866.5910.............  Quality Control  NZB         ....................
                        Material,
                        Genetics, DNA.
868.1040.............  Algesimeter,     BSI         ....................
                        Powered.
868.1400.............  Legging,         LLK         ....................
                        Compression,
                        Non-Inflatable.
868.2385.............  Analyzer,        MRQ         Exemption is limited
                        Nitrogen                     to standalone
                        Dioxide.                     nitrogen dioxide
                                                     analyzers and not
                                                     those that are
                                                     components of
                                                     nitric oxide
                                                     delivery systems
                                                     intended to monitor
                                                     nitrogen dioxide
                                                     levels during
                                                     inhaled nitric
                                                     oxide therapy.
868.2500.............  Monitor,         KLK         ....................
                        Oxygen,
                        Cutaneous, For
                        Infant Not
                        Under Gas
                        Anesthesia.
868.2500.............  Monitor,         LPP         ....................
                        Oxygen,
                        Cutaneous, For
                        Uses Other
                        Than For
                        Infant Not
                        Under Gas
                        Anesthesia.
868.2550.............  Pneumotachomete  JAX         ....................
                        r.
868.5180.............  Bed, Rocking,    CCO         ....................
                        Breathing
                        Assist.
868.6250.............  Compressor,      BTI         ....................
                        Air, Portable.
870.1330.............  Wire, Guide,     DQX         Exemption is limited
                        Catheter.                    to accessory torque
                                                     devices that are
                                                     manually operated,
                                                     non-patient
                                                     contacting, and
                                                     intended to
                                                     manipulate non-
                                                     cerebral vascular
                                                     guide wires.
870.1390.............  Trocar.........  DRC         ....................
870.1650.............  Syringe,         MAV         Exemption is limited
                        Balloon                      to non-patient
                        Inflation.                   contacting balloon
                                                     inflation syringes
                                                     intended only to
                                                     inflate/deflate
                                                     balloon catheters
                                                     and monitor
                                                     pressure within the
                                                     balloon.
870.1875.............  Lung Sound       OCR         ....................
                        Monitor.
870.2675.............  Oscillometer...  DRZ         ....................
870.2770.............  Analyzer, Body   MNW         Exemption is limited
                        Composition.                 to body composition
                                                     analyzers which are
                                                     not intended to
                                                     diagnose or treat
                                                     any medical
                                                     condition.
870.4280.............  Filter,          KRJ         ....................
                        Prebypass,
                        Cardiopulmonar
                        y Bypass.
870.4290.............  Adaptor,         DTL         ....................
                        Stopcock,
                        Manifold,
                        Fitting,
                        Cardiopulmonar
                        y Bypass.
870.4340.............  Monitor and/or   DTW         ....................
                        Control, Level
                        Sensing,
                        Cardiopulmonar
                        y Bypass.
870.4400.............  Reservoir,       DTN         Exemption is limited
                        Blood,                       to cardiopulmonary
                        Cardiopulmonar               bypass blood
                        y Bypass.                    reservoirs that do
                                                     not contain
                                                     defoamers or blood
                                                     filters.
870.4420.............  Sucker,          DTS         ....................
                        Cardiotomy
                        Return,
                        Cardiopulmonar
                        y Bypass.
870.4430.............  Suction          DWD         ....................
                        Control,
                        Intracardiac,
                        Cardiopulmonar
                        y Bypass.
872.1720.............  Tester, Pulp...  EAT         ....................

872.3260.............  External         PME         ....................
                        Cleaning
                        Solution.
872.3300.............  Coating,         EBE         ....................
                        Denture
                        Hydrophilic,
                        Resin.
872.3540.............  Pad, Denture,    EHR         ....................
                        Over The
                        Counter.
872.3540.............  Cushion,         EHS         ....................
                        Denture, Over
                        The Counter.
872.3560.............  Reliner,         EBP         ....................
                        Denture, Over
                        The Counter.
872.3590.............  Denture,         ELM         ....................
                        Plastic, Tooth.
872.3600.............  Denture          EKO         ....................
                        Preformed
                        (Partially
                        Prefabricated
                        Denture).
872.3890.............  Splint,          ELS         ....................
                        Endodontic
                        Stabilizing.
872.5550.............  Ring, Teething,  KKO         ....................
                        Fluid-Filled.