External Positive Control for Inf A/H1 consists of lyophilized plasmid DNA containing the cloned target sequence of the hemagglutinin gene of the 2009 H1N1 virus. The Inf A/H1
     Positive Control is incorporated into each batch of patient specimen testing for the Inf A/H1 target.

     Negative Control consists of nuclease free water and is taken through both nucleic acid extraction and PCR processes to demonstrate that no carryover contamination has occurred
     during the test process. The Negative Control is incorporated into each batch of patient specimen processing.

 The Roche RealTime ready Influenza A/H1N1 Detection Set requires the following hardware with corresponding software:

     MagNA Pure LC 1.0 Instrument or
     MagNA Pure LC 2.0 Instrument
     LightCycler[reg] 2.0 Instrument
     LightCycler[reg] Software Version 4
     LightCycler[reg] Capillaries (20 ml)
     LightCycler[reg] Centrifuge Adapters
     LightCycler[reg] Capping Tool

 Optional hardware:

     LC Carousel Centrifuge 2.0 including rotor buckets or
     LC Carousel Centrifuge and LC Carousel Centrifuge 2.0 Rotor Set

 The Roche RealTime ready Influenza A/H1N1 Detection Set requires the use of the following additional reagents/materials:

     MagNA Pure LC Total Nucleic Acid Isolation Kit - High Performance
     RealTime ready RNA Virus Master

 The above described Roche RealTime ready Influenza A/H1N1 Detection Set, when labeled consistently with the labeling authorized by FDA, entitled RealTime ready Influenza A/H1N1 Detection Set
 Package Insert, (see http://www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161496.htm), as may be revised with written permission of FDA, is authorized to be distributed to CLIA
 High Complexity Laboratories under this EUA, despite the fact that it does not meet certain requirements otherwise required by federal law.

 The above described Roche RealTime ready Influenza A/H1N1 Detection Set is authorized to be accompanied by the following information pertaining to the emergency use, which are authorized to
 be made available to healthcare providers and patients:

     Fact Sheet for Healthcare Providers: Interpreting the Roche RealTime ready Influenza A/H1N1 Detection Set Test Results

     Fact Sheet for Patients: Understanding the Roche RealTime ready Influenza A/H1N1 Detection Set Test Results

 As described in section IV below, Roche Diagnostics GmbH, is also authorized to make available additional information relating to the emergency use of the authorized Roche RealTime ready
 Influenza A/H1N1 Detection Set that is consistent with, and does not exceed, the terms of this letter of authorization.

 I have concluded, pursuant to section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of the authorized Roche RealTime ready Influenza A/H1N1
 Detection Set in the specified population, when used for diagnosis of 2009 H1N1 influenza virus infection, outweigh the known and potential risks of such a product.

 I have concluded, pursuant to section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that the authorized Roche RealTime
 ready Influenza A/H1N1 Detection Set may be effective in the diagnosis of 2009 H1N1 influenza virus infection pursuant to section 564(c)(2)(A) of the Act. The FDA has reviewed the scientific
 information available including the information supporting the conclusions described in Section I above, and concludes that the authorized Roche RealTime ready Influenza A/H1N1 Detection Set,
 when used to diagnose 2009 H1N1 influenza virus infection in the specified population, meets the criteria set forth in section 564(c) of the Act concerning safety and potential effectiveness.

 The emergency use of the authorized Roche RealTime ready Influenza A/H1N1 Detection Set under this EUA must be consistent with, and may not exceed, the terms of this letter, including the
 scope and the conditions of authorization set forth below. Subject to the terms of this EUA and under the circumstances set forth in the Secretary of HHS' determination under section
 564(b)(1)(C) described above and the Secretary of HHS' corresponding declaration under section 564(b)(1), the Roche RealTime ready Influenza A/H1N1 Detection Set described above is authorized
 to diagnose 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory infection.

 This EUA will cease to be effective when the declaration of emergency is terminated under section 564(b)(2) of the Act or when the EUA is revoked under section 564(g) of the Act.

 III. Waiver of Certain Requirements

 I am waiving the following requirements for the Roche RealTime ready Influenza A/H1N1 Detection Set during the duration of this emergency use authorization:

     Current good manufacturing practice requirements, including the quality system requirements under 21 CFR Part 820 with respect to the design, manufacture, packaging, labeling,
     storage, and distribution of the Roche RealTime ready Influenza A/H1N1 Detection Set.

     Labeling requirements for cleared, approved, or investigational devices, including labeling requirements under 21 CFR 809.10 and 809.30, except for the intended use statement (21
     CFR 809.10(a)(2), (b)(2)), adequate directions for use (21 U.S.C. 352(f)), (21 CFR 809.10(b)(5) and (8)), any appropriate limitations on the use of the device including information
     required under 21 CFR 809.10(a)(4), and any available information regarding performance of the device, including requirements under 21 CFR 809.10(b)(12).

 IV. Conditions of Authorization

 Pursuant to section 564 of the Act, I am establishing the following conditions on this authorization:

 Roche Diagnostics GmbH

    A. Roche Diagnostics GmbH will distribute the authorized Roche RealTime ready Influenza A/H1N1 Detection Set with the authorized labeling, as may be revised with written permission of FDA,
     only to CLIA High Complexity Laboratories.

    B. Roche Diagnostics GmbH will provide to the CLIA High Complexity Laboratories the authorized Roche RealTime ready Influenza A/H1N1 Detection Set Fact Sheets for Healthcare Providers and
     the authorized Roche RealTime ready Influenza A/H1N1 Detection Set Fact Sheets for Patients.

    C. Roche Diagnostics GmbH will make available on its website the authorized Roche RealTime ready Influenza A/H1N1 Detection Set Fact Sheets for Healthcare Providers and the authorized
     Roche RealTime ready Influenza A/H1N1 Detection Set Fact Sheets for Patients.

    D. Roche Diagnostics GmbH will inform state and/or local public health authority(ies) of this EUA, including the terms and conditions herein.

    E. All advertising and promotional descriptive printed matter relating to the use of the authorized Roche RealTime ready Influenza A/H1N1 Detection Set shall be consistent with the Fact
     Sheets and authorized labeling, as well as the terms set forth in this EUA and other requirements set forth in the Act and FDA regulations.

    F. All advertising and promotional descriptive printed matter relating to the use of the authorized Roche RealTime ready Influenza A/H1N1 Detection Set shall clearly and conspicuously
     state that:

       This test has not been FDA cleared or approved;

       This test has been authorized by FDA under an Emergency Use Authorization;

       This test has been authorized only for the detection of 2009 H1N1 influenza virus and not for any other viruses or pathogens;

       This test is only authorized for the duration of the declaration of emergency under section 564(b)(1) of the Act, 21 U.S.C. Sec.  360bbb-3(b)(1); and

       The declaration of emergency will expire on April 26, 2010, unless it is terminated or revoked sooner or renewed.

    G. No advertising or promotional descriptive printed matter relating to the use of the authorized Roche RealTime ready Influenza A/H1N1 Detection Set may represent or suggest that this
     test is safe or effective for the diagnosis of 2009 H1N1 influenza virus.

    H. Roche Diagnostics GmbH will ensure that CLIA High Complexity Laboratories using the authorized Roche RealTime ready Influenza A/H1N1 Detection Set have a process in place for reporting
     test results to healthcare providers and federal, state and/or local public health authorities, as appropriate.

    I. Roche Diagnostics GmbH will track adverse events and report to FDA as required under 21 CFR part 803.

    J. Through a process of inventory control, Roche Diagnostics GmbH will maintain records of device usage.

    K. Roche Diagnostics GmbH will collect information on the performance of the assay and report to FDA any suspected occurrence of false positive or negative results of which Roche
     Diagnostics GmbH becomes aware.

    CLIA High Complexity Laboratories

    L. CLIA High Complexity Laboratories will include with reports of the results of the Roche RealTime ready Influenza A/H1N1 Detection Set the authorized Fact Sheets for Healthcare Providers
     and the authorized Fact Sheets for Patients.

    M. CLIA High Complexity Laboratories will use the MagNA Pure LC Instrument and the MagNA Pure LC Total Nucleic Acid Isolation Kit - High Performance for nucleic acid extraction and perform
     the assay on the LightCycler[reg] V2.0 instrument.

    N. CLIA High Complexity Laboratories will have a process in place for reporting test results to healthcare providers and federal, state and/or local public health authorities, as
     appropriate

    O. CLIA High Complexity Laboratories will collect information on the performance of the assay, and report to Roche Diagnostics GmbH any suspected occurrence of false positive or false
     negative results of which CLIA High Complexity Laboratories become aware.

    Roche Diagnostics GmbH and CLIA High Complexity Laboratories

    P. Roche Diagnostics GmbH is authorized to make available additional information relating to the emergency use of the authorized Roche RealTime ready Influenza A/H1N1 Detection Set that is
     consistent with, and does not exceed, the terms of this letter of authorization.

    Q. Only Roche Diagnostics GmbH may request changes to the authorized Roche RealTime ready Influenza A/H1N1 Detection Set Fact Sheet for Healthcare Providers or the authorized Roche
     RealTime ready Influenza A/H1N1 Detection Set Fact Sheet for Patients. Such requests will be made by contacting FDA concerning FDA review and approval.

    R. Roche Diagnostics GmbH will ensure that any records associated with this EUA are maintained until notified by FDA. Such records will be made available to FDA for inspection upon
     request.

 The emergency use of the authorized Roche RealTime ready Influenza A/H1N1 Detection Set as described in this letter of authorization must comply with the conditions above and all other terms
 of this authorization.

 V. Duration of Authorization

 This EUA will be effective until the declaration of emergency is terminated under section 564(b)(2) of the Act or the EUA is revoked under section 564(g) of the Act.

                   Margaret A. Hamburg, M.D.
                   Commissioner of Food and Drugs

 \1\ Memorandum, Determination Pursuant to Sec.   564 of the Federal Food, Drug, and Cosmetic Act (April 26, 2009).
\2\ No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act.

    (8) The Authorization for the GeneSTAT 2009 A/H1N1 Influenza Test
issued on December 9, 2009, follows and provides an explanation of the
reasons for its issuance, as required by section 564(h)(1) of the act:

 Mark J. Rosenfeld, M.S., Ph.D.
 Chief Science Advisor, DxNA, LLC
 3879 S. River Road, Bldg. A
 St. George, UT 84790

 Dear Dr. Rosenfeld:

 This letter is in response to your request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for emergency use of the GeneSTAT 2009 A/H1N1 Influenza Test
 for the diagnosis of 2009 H1N1 influenza virus infection in patients with signs and symptoms of respiratory infection, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the
 Act) (21 U.S.C. Sec.  360bbb-3), by CLIA High Complexity Laboratories, which are laboratories certified under the Clinical Laboratory Improvement Amendments of 1988, 42 U.S.C. Sec.  263a, to
 perform high complexity tests.

 On April 26, 2009, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. Sec.  360bbb-3(b)(1)(C)), the Secretary of the Department of Health and Human Services (HHS) determined that there is
 a public health emergency under 42 U.S.C. Sec.  247d that affects, or has a significant potential to affect, national security, and that involves a specified biological, chemical,
 radiological, or nuclear agent or agents, or a specified disease or condition that may be attributable to such an agent or agents - in this case, 2009 H1N1 influenza virus.\1\ Pursuant to
 section 564(b) of the Act (21 U.S.C. Sec.  360bbb-3(b)), and on the basis of such determination, the Secretary of HHS then declared an emergency justifying the authorization of the emergency
 use of certain in vitro diagnostics for the detection of 2009 H1N1 influenza virus, subject to the terms of any authorization issued under 21 U.S.C. Sec.  360bbb-3(a).

 Having concluded that the criteria for issuance of this authorization under section 564(c) of the Act (21 U.S.C. Sec.  360bbb-3(c)) are met, I am authorizing the emergency use of the GeneSTAT
 2009 A/H1N1 Influenza Test (as described in the scope section of this letter (Section II)) for the diagnosis of 2009 H1N1 influenza virus infection in individuals with signs and symptoms of
 respiratory infection, subject to the terms of this authorization.

 I. Criteria for Issuance of Authorization

 I have concluded that the emergency use of the GeneSTAT 2009 A/H1N1 Influenza Test for the diagnosis of 2009 H1N1 influenza virus infection in individuals with signs and symptoms of
 respiratory infection meets the criteria for issuance of an authorization under section 564(c) of the Act, because I have concluded that:

    1. The 2009 H1N1 influenza virus can cause influenza, a serious or life threatening disease or condition to humans infected by this virus;

    2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that the GeneSTAT 2009 A/H1N1 Influenza Test may be effective for the diagnosis of 2009 H1N1
     influenza virus infection, and that the known and potential benefits of the GeneSTAT 2009 A/H1N1 Influenza Test, when used in the diagnosis of 2009 H1N1 influenza virus infection,
     outweigh the known and potential risks of such product; and

    3. There is no adequate, approved, and available alternative to the emergency use of the GeneSTAT 2009 A/H1N1 Influenza Test for the diagnosis of 2009 H1N1 influenza virus infection.\2\

 II. Scope of Authorization

 I have concluded, pursuant to section 564(d)(1) of the Act, that the scope of this authorization is limited to the use of the authorized GeneSTAT 2009 A/H1N1 Influenza Test for the diagnosis
 of 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory infection.

 The Authorized GeneSTAT 2009 A/H1N1 Influenza Test:

 The GeneSTAT 2009 A/H1N1 Influenza Test is a reverse-transcription polymerase chain reaction assay for the in vitro qualitative detection of 2009 H1N1 influenza viral RNA in nasopharyngeal
 swabs or nasal swabs from patients with signs and symptoms of respiratory infection. The GeneSTAT 2009 A/H1N1 Influenza Test is to be used in combination with the Roche High Pure RNA
 Isolation Kit and the GeneSTAT Analytical Platform. The assay is composed of two principal steps: (1) extraction of RNA from patient specimens, (2) one-step reverse transcription and PCR
 amplification using fluorogenic probes for detection.

 The GeneSTAT 2009 A/H1N1 Influenza Test includes the following primer and probe sets:

     H1: a primer-probe set designed to detect the presence of the hemagglutinin gene specifically found in the 2009 H1N1 influenza A virus.
     N1: a primer-probe set designed to detect the presence of the neuraminidase gene specifically found in the 2009 H1N1 influenza A virus.
     MA: a primer-probe set designed to detect the presence of a well conserved region of the matrix gene found in both, seasonal human influenza A virus and 2009 H1N1 influenza A
     virus.
     P28: a primer-probe set designed to detect the presence of the Caprine Arthritis-Encephalitis Virus core polypeptide p28 gene (Exogenous Reaction Control).

 The GeneSTAT 2009 A/H1N1 Influenza Test also includes the following control materials:

     Influenza A Matrix-Positive Control Swab.
     H1-Positive Control Swab (2009 H1N1 specific).

 The GeneSTAT 2009 A/H1N1 Influenza Test requires the following hardware with corresponding software:

     GeneSTAT Analytical Platform.

 The GeneSTAT 2009 A/H1N1 Influenza Test requires the use of the following additional reagents/materials:

     GeneSTAT H1N1 Test Module.
     GeneSTAT Sample Prep Vial.
     Roche High Pure RNA Isolation Kit.

 The above described GeneSTAT 2009 A/H1N1 Influenza Test, when labeled consistently with the labeling authorized by FDA, entitled GeneSTAT\TM\ 2009 A/H1N1 Influenza Test Package Insert, (see
 http://www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161496.htm), as may be revised with written permission of FDA, is authorized to be distributed to CLIA High Complexity
 Laboratories under this EUA, despite the fact that it does not meet certain requirements otherwise required by federal law.

 The above described GeneSTAT 2009 A/H1N1 Influenza Test is authorized to be accompanied by the following information pertaining to the emergency use, which is authorized to be made available
 to healthcare providers and patients:

     Fact Sheet for Healthcare Providers: Interpreting GeneSTAT 2009 A/H1N1 Influenza Test Results

     Fact Sheet for Patients: Understanding the GeneSTAT 2009 A/H1N1 Influenza Test Results

 As described in section IV below, DxNA, LLC, is also authorized to make available additional information relating to the emergency use of the authorized GeneSTAT 2009 A/H1N1 Influenza Test
 that is consistent with, and does not exceed, the terms of this letter of authorization.

 I have concluded, pursuant to section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of the authorized GeneSTAT 2009 A/H1N1 Influenza Test in the
 specified population, when used for diagnosis of 2009 H1N1 influenza virus infection, outweigh the known and potential risks of such a product.

 I have concluded, pursuant to section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that the authorized GeneSTAT 2009 A/
 H1N1 Influenza Test may be effective in the diagnosis of 2009 H1N1 influenza virus infection pursuant to section 564(c)(2)(A) of the Act. The FDA has reviewed the scientific information
 available including the information supporting the conclusions described in Section I above, and concludes that the authorized GeneSTAT 2009 A/H1N1 Influenza Test, when used to diagnose 2009
 H1N1 influenza virus infection in the specified population, meets the criteria set forth in section 564(c) of the Act concerning safety and potential effectiveness.

 The emergency use of the authorized GeneSTAT 2009 A/H1N1 Influenza Test under this EUA must be consistent with, and may not exceed, the terms of this letter, including the scope and the
 conditions of authorization set forth below. Subject to the terms of this EUA and under the circumstances set forth in the Secretary of HHS' determination under section 564(b)(1)(C) described
 above and the Secretary of HHS' corresponding declaration under section 564(b)(1), the GeneSTAT 2009 A/H1N1 Influenza Test described above is authorized to diagnose 2009 H1N1 influenza virus
 infection in individuals with signs and symptoms of respiratory infection.

 This EUA will cease to be effective when the declaration of emergency is terminated under section 564(b)(2) of the Act or when the EUA is revoked under section 564(g) of the Act.

 III. Waiver of Certain Requirements

 I am waiving the following requirements for the GeneSTAT 2009 A/H1N1 Influenza Test during the duration of this emergency use authorization:

     Current good manufacturing practice requirements, including the quality system requirements under 21 CFR Part 820 with respect to the design, manufacture, packaging, labeling,
     storage, and distribution of the GeneSTAT 2009 A/H1N1 Influenza Test.

     Labeling requirements for cleared, approved, or investigational devices, including labeling requirements under 21 CFR 809.10 and 809.30, except for the intended use statement (21
     CFR 809.10(a)(2), (b)(2)), adequate directions for use (21 U.S.C. 352(f)), (21 CFR 809.10(b)(5) and (8)), any appropriate limitations on the use of the device including information
     required under 21 CFR 809.10(a)(4), and any available information regarding performance of the device, including requirements under 21 CFR 809.10(b)(12).

 IV. Conditions of Authorization

 Pursuant to section 564 of the Act, I am establishing the following conditions on this authorization:

    DxNA, LLC

    A. DxNA, LLC will distribute the authorized GeneSTAT 2009 A/H1N1 Influenza Test with the authorized labeling, as may be revised with written permission of FDA, only to CLIA High Complexity
     Laboratories.

    B. DxNA, LLC will provide to the CLIA High Complexity Laboratories the authorized GeneSTAT 2009 A/H1N1 Influenza Test Fact Sheets for Healthcare Providers and the authorized GeneSTAT 2009
     A/H1N1 Influenza Test Fact Sheets for Patients.

    C. DxNA, LLC will make available on its website the authorized GeneSTAT 2009 A/H1N1 Influenza Test Fact Sheets for Healthcare Providers and the authorized GeneSTAT 2009 A/H1N1 Influenza
     Test Fact Sheets for Patients.

    D. DxNA, LLC will inform state and/or local public health authority(ies) of this EUA, including the terms and conditions herein.

    E. All advertising and promotional descriptive printed matter relating to the use of the authorized GeneSTAT 2009 A/H1N1 Influenza Test shall be consistent with the Fact Sheets and
     authorized labeling, as well as the terms set forth in this EUA and other requirements set forth in the Act and FDA regulations.

    F. All advertising and promotional descriptive printed matter relating to the use of the authorized GeneSTAT 2009 A/H1N1 Influenza Test shall clearly and conspicuously state that:

       This test has not been FDA cleared or approved;

       This test has been authorized by FDA under an Emergency Use Authorization;

       This test has been authorized only for the detection of 2009 H1N1 influenza virus and not for any other viruses or pathogens;

       This test is only authorized for the duration of the declaration of emergency under section 564(b)(1) of the Act, 21 U.S.C. Sec.  360bbb-3(b)(1); and

       The declaration of emergency will expire on April 26, 2010, unless it is terminated or revoked sooner or renewed.

    G. No advertising or promotional descriptive printed matter relating to the use of the authorized GeneSTAT 2009 A/H1N1 Influenza Test may represent or suggest that this test is safe or
     effective for the diagnosis of 2009 H1N1 influenza virus.

    H. DxNA, LLC will ensure that CLIA High Complexity Laboratories using the authorized GeneSTAT 2009 A/H1N1 Influenza Test have a process in place for reporting test results to healthcare
     providers and federal, state and/or local public health authorities, as appropriate.

    I. DxNA, LLC will track adverse events and report to FDA as required under 21 CFR part 803.

    J. Through a process of inventory control, DxNA, LLC will maintain records of device usage.

    K. DxNA, LLC will collect information on the performance of the assay and report to FDA any suspected occurrence of false positive or negative results of which DxNA, LLC becomes aware.

    CLIA High Complexity Laboratories

    L. CLIA High Complexity Laboratories will include with reports of the results of the GeneSTAT 2009 A/H1N1 Influenza Test the authorized Fact Sheets for Healthcare Providers and the
     authorized Fact Sheets for Patients.

    M. CLIA High Complexity Laboratories will use the Roche High Pure RNA Isolation Kit for nucleic acid extraction and perform the assay on the GeneSTAT Analytical Platform, ensuring that at
     least once per day that specimens are to be tested, a known sample (2009 H1N1 positive or influenza A positive specimen) is tested as a positive control for RNA extraction and subsequent
     protocol steps.

    N. CLIA High Complexity Laboratories will have a process in place for reporting test results to healthcare providers and federal, state and/or local public health authorities, as
     appropriate.

    O. CLIA High Complexity Laboratories will collect information on the performance of the assay, and report to DxNA, LLC any suspected occurrence of false positive or false negative results
     of which CLIA High Complexity Laboratories become aware.

    DxNA, LLC and CLIA High Complexity Laboratories

    P. DxNA, LLC is authorized to make available additional information relating to the emergency use of the authorized GeneSTAT 2009 A/H1N1 Influenza Test that is consistent with, and does
     not exceed, the terms of this letter of authorization.

    Q. Only DxNA, LLC may request changes to the authorized GeneSTAT 2009 A/H1N1 Influenza Test Fact Sheet for Healthcare Providers or the authorized GeneSTAT 2009 A/H1N1 Influenza Test Fact
     Sheet for Patients. Such requests will be made by contacting FDA concerning FDA review and approval.

    R. DxNA, LLC will ensure that any records associated with this EUA are maintained until notified by FDA. Such records will be made available to FDA for inspection upon request.

 The emergency use of the authorized GeneSTAT 2009 A/H1N1 Influenza Test as described in this letter of authorization must comply with the conditions above and all other terms of this
 authorization.

 V. Duration of Authorization

 This EUA will be effective until the declaration of emergency is terminated under section 564(b)(2) of the Act or the EUA is revoked under section 564(g) of the Act.

                   Margaret A. Hamburg, M.D.
                   Commissioner of Food and Drugs

 \1\ Memorandum, Determination Pursuant to Sec.   564 of the Federal Food, Drug, and Cosmetic Act (April 26, 2009).
\2\ No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act.

    (9) The Authorization for the TessArray Resequencing Influenza A
Microarray Detection Panel issued on December 16, 2009, follows and
provides an explanation of the reasons for its issuance, as required by
section 564(h)(1) of the act:

 Clark Tibbetts, PhD
 Executive Vice President
 TessArae, LLC
 46090 Lake Center Plaza
 Suite 304
 Sterling, VA 20165

 Dear Dr. Tibbetts:

 This letter is in response to your request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) pursuant to section 564 of the Federal Food, Drug, and
 Cosmetic Act (the Act) (21 U.S.C. Sec.  360bbb-3) for emergency use of the TessArray[reg] Resequencing Influenza A Microarray Detection Panel (TessArray RM-Flu) for the diagnosis of 2009 H1N1
 influenza virus infection aided by an algorithm that relies on seasonal influenza A/H1 virus and seasonal influenza A/H3 virus results, in patients with signs and symptoms of respiratory
 infection, by CLIA High Complexity Laboratories, which are laboratories certified under the Clinical Laboratory Improvement Amendments of 1988, 42 U.S.C. Sec.  263a, to perform high
 complexity tests.

 On April 26, 2009, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. Sec.  360bbb-3(b)(1)(C)), the Secretary of the Department of Health and Human Services (HHS) determined that there is
 a public health emergency under 42 U.S.C. Sec.  247d that affects, or has a significant potential to affect, national security, and that involves a specified biological, chemical,
 radiological, or nuclear agent or agents, or a specified disease or condition that may be attributable to such an agent or agents - in this case, 2009 H1N1 influenza virus.\1\ Pursuant to
 section 564(b) of the Act (21 U.S.C. Sec.  360bbb-3(b)), and on the basis of such determination, the Secretary of HHS then declared an emergency justifying the authorization of the emergency
 use of certain in vitro diagnostics for the detection of 2009 H1N1 influenza virus, subject to the terms of any authorization issued under 21 U.S.C. Sec.  360bbb-3(a).

 Having concluded that the criteria for issuance of this authorization under section 564(c) of the Act (21 U.S.C. Sec.  360bbb-3(c)) are met, I am authorizing the emergency use of the
 TessArray RM-Flu (as described in the scope section of this letter (Section II)) for the diagnosis of 2009 H1N1 influenza virus infection aided by an algorithm that relies on seasonal
 influenza A/H1 virus and seasonal influenza A/H3 virus results, in individuals with signs and symptoms of respiratory infection, subject to the terms of this authorization.

 I. Criteria for Issuance of Authorization

 I have concluded that the emergency use of the TessArray RM-Flu for the diagnosis of 2009 H1N1 influenza virus infection aided by an algorithm that relies on seasonal influenza A/H1 virus and
 seasonal influenza A/H3 virus results, in individuals with signs and symptoms of respiratory infection meets the criteria for issuance of an authorization under section 564(c) of the Act,
 because I have concluded that:

    1. The 2009 H1N1 influenza virus can cause influenza, a serious or life threatening disease or condition to humans infected by this virus.

    2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that the TessArray RM-Flu may be effective for the diagnosis of 2009 H1N1 influenza virus
     infection, and that the known and potential benefits of the TessArray RM-Flu, when used in the diagnosis of 2009 H1N1 influenza virus infection, outweigh the known and potential risks of
     such product; and

    3. There is no adequate, approved, and available alternative to the emergency use of the TessArray RM-Flu for the diagnosis of 2009 H1N1 influenza virus infection.\2\

 II. Scope of Authorization

 I have concluded, pursuant to section 564(d)(1) of the Act, that the scope of this authorization is limited to the use of the authorized TessArray RM-Flu for the diagnosis of 2009 H1N1
 influenza virus infection aided by an algorithm that relies on seasonal influenza A/H1 virus and seasonal influenza A/H3 virus results, in individuals with signs and symptoms of respiratory
 infection.

 The Authorized TessArray RM-Flu:

 The TessArray RM-Flu is a resequencing microarray assay for the in vitro qualitative detection of 2009 H1N1 influenza viral RNA in throat swabs from patients with signs and symptoms of
 respiratory infection. The TessArray RM-Flu is to be used in combination with the EPICENTRE Masterpure\TM\ Complete DNA and RNA Purification Kit and the Affymetrix[reg] GeneChip[reg]
 Microarray Instrumentation System. The assay protocol follows a number of steps, starting from RNA extraction from patient specimens, through reverse transcription and amplification by
 multiplex PCR, followed by labeling of fragmented DNA and hybridization to a microarray. After washing, the array is stained with fluorescent dye and subsequently scanned. The image analysis
 readout sequence from the detector tiles in the array is scored and also submitted for BLAST homology determination, to define the most similar homology with any known flu virus sequence.

 The gene resequencing detector tiles of the TessArray RM-Flu assay represent:

     2009 H1N1 influenza virus
       NA1av an avian type A influenza virus neuraminidase gene sequence
       NSav an avian type A influenza virus non-structural gene sequence
       M1hu a representative matrix gene sequence from seasonal A/H1N1
       M3hu a representative matrix gene sequence from seasonal A/H3N2
       M5Av an avian type A influenza virus matrix gene sequence
     Seasonal A/H1N1
       HA1hu a representative hemagglutinin gene sequence from A/H1N
       NA1hu a representative neuraminidase gene sequence from A/H1N1
       M1hu a representative matrix gene sequence from seasonal A/H1N1
       M3hu a representative matrix gene sequence from seasonal A/H3N2
       M5Av an avian type A influenza virus matrix gene sequence
     Seasonal A/H3N2
       HA3hu a representative hemagglutinin gene sequence from A/H1N1
       NA2hu a representative neuraminidase gene sequence from A/H1N1
       M1hu a representative matrix gene sequence from seasonal A/H1N1
       M3hu a representative matrix gene sequence from seasonal A/H3N2
       M5Av an avian type A influenza virus matrix gene sequence

 The TessArray RM-Flu assay also includes the following control detector tiles:

 Negative/Background Controls: 25 non-analyte resequencing detector tiles as background control detector tiles representing a variety of different type A influenza virus HA and NA genes, from
 subtypes that rarely infect humans. They are used to set a threshold for detection of the assay's targeted influenza viruses and to monitor resequencing data quality of the assay.

 Positive/Protocol Controls: Each batch of specimens to be tested should include a known sample, such as that of a seasonal influenza virus vaccine, as a positive control for RNA extraction
 and subsequent protocol steps. Two additional resequencing detector tiles represent over 1,000 nucleotides of sequences of the TIM and NAC1 genes from Arabidopsis thaliana (wild mustard
 weed). Template controls are included in each specimen. Positive scoring of these controls provides assurance of successful execution of the different steps in the sample processing.

 The TessArray RM-Flu assay requires the following hardware with corresponding software:

     Thermal Cyclers that were tested with the RM-Flu Multiplex PCR:
       Bio-Rad MJ Mini
       Bio-Rad MyCycler
       Bio-Rad Peltier DNA Engine Tetrad
     Affymetrix[reg] GeneChip[reg] Microarray Instrumentation Systems tested:
       GCS 3000 7G (RUO)
       GCS 3000Dx (IVD)
       GCS 3000Dx2 (IVD)
     Workstation and Software:
       GCOS/GSEQ
       AGCC/GSEQ
       AGCC-Dx or AGCC-Dx2

 The TessArray RM-Flu assay requires the use of the following additional reagents/materials:

     EPICENTRE[reg] Biotechnologies Masterpure\TM\ Complete DNA and RNA Purification Kit
     Life Technologies\TM\ Superscript\TM\ III Reverse Transcriptase
     Life Technologies\TM\ RNaseOUT\TM\ Recombinant Ribonuclease Inhibitor
     Promega[reg], GoTaq[reg] Flexi DNA Polymerase
     USB (Affymetrix[reg]) Uracil-DNA Glycosylase (UDG), Heat-Labile
     Qiagen[reg] QIAquick[reg] PCR Purification Kit
     Affymetrix[reg] GeneChip[reg] Resequencing Assay Kit

 The above described TessArray RM-Flu test, when labeled consistently with the labeling authorized by FDA, entitled TessArray RM-Flu Package Insert, (available at http://www.fda.gov/
 MedicalDevices/Safety/EmergencySituations/ucm161496.htm), as may be revised with written permission of FDA, is authorized to be distributed to and used by CLIA High Complexity Laboratories
 under this EUA, despite the fact that it does not meet certain requirements otherwise required by federal law.

 The above described TessArray RM-Flu is authorized to be accompanied by the following information pertaining to the emergency use, which is authorized to be made available to healthcare
 providers and patients:

     Fact Sheet for Healthcare Providers: Interpreting TessArray[reg] Resequencing Influenza A Microarray Detection Panel (TessArray RM-Flu) Test Results

     Fact Sheet for Patients: Understanding the TessArray[reg] Resequencing Influenza A Microarray Detection Panel (TessArray RM-Flu) Test Results

 As described in section IV below, TessArae, LLC, is also authorized to make available additional information relating to the emergency use of the authorized TessArray RM-Flu that is
 consistent with, and does not exceed, the terms of this letter of authorization.

 I have concluded, pursuant to section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of the authorized TessArray RM-Flu in the specified
 population, when used for diagnosis of 2009 H1N1 influenza virus infection aided by an algorithm that relies on seasonal influenza A/H1 virus and seasonal influenza A/H3 virus results,
 outweigh the known and potential risks of such a product.

 I have concluded, pursuant to section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that the authorized TessArray RM-
 Flu may be effective in the diagnosis of 2009 H1N1 influenza virus infection aided by an algorithm that relies on seasonal influenza A/H1 virus and seasonal influenza A/H3 virus results,
 pursuant to section 564(c)(2)(A) of the Act. The FDA has reviewed the scientific information available including the information supporting the conclusions described in Section I above, and
 concludes that the authorized TessArray RM-Flu, when used to diagnose 2009 H1N1 influenza virus infection aided by an algorithm that relies on seasonal influenza A/H1 virus and seasonal
 influenza A/H3 virus results in the specified population, meets the criteria set forth in section 564(c) of the Act concerning safety and potential effectiveness.

 The emergency use of the authorized TessArray RM-Flu under this EUA must be consistent with, and may not exceed, the terms of this letter, including the scope and the conditions of
 authorization set forth below. Subject to the terms of this EUA and under the circumstances set forth in the Secretary of HHS's determination under section 564(b)(1)(C) described above and
 the Secretary of HHS's corresponding declaration under section 564(b)(1), the TessArray RM-Flu described above is authorized to diagnose 2009 H1N1 influenza virus infection aided by an
 algorithm that relies on seasonal influenza A/H1 virus and seasonal influenza A/H3 virus results, in individuals with signs and symptoms of respiratory infection.

 This EUA will cease to be effective when the declaration of emergency is terminated under section 564(b)(2) of the Act or when the EUA is revoked under section 564(g) of the Act.

 III. Waiver of Certain Requirements

 I am waiving the following requirements for the TessArray RM-Flu during the duration of this emergency use authorization:

     Current good manufacturing practice requirements, including the quality system requirements under 21 CFR Part 820 with respect to the design, manufacture, packaging, labeling,
     storage, and distribution of the TessArray RM-Flu.

     Labeling requirements for cleared, approved, or investigational devices, including labeling requirements under 21 CFR 809.10 and 809.30, except for the intended use statement (21
     CFR 809.10(a)(2), (b)(2)), adequate directions for use (21 U.S.C. 352(f)), (21 CFR 809.10(b)(5) and (8)), any appropriate limitations on the use of the device including information
     required under 21 CFR 809.10(a)(4), and any available information regarding performance of the device, including requirements under 21 CFR 809.10(b)(12).

 IV. Conditions of Authorization

 Pursuant to section 564 of the Act, I am establishing the following conditions on this authorization:

    TessArae, LLC

    A. TessArae, LLC will distribute the authorized TessArray RM-Flu with the authorized labeling, as may be revised with written permission of FDA, only to CLIA High Complexity Laboratories.

    B. TessArae, LLC will provide to the CLIA High Complexity Laboratories the authorized TessArray RM-Flu Fact Sheet for Healthcare Providers and the authorized TessArray RM-Flu Fact Sheet
     for Patients.

    C. TessArae, LLC will make available on its website the authorized TessArray RM-Flu Fact Sheet for Healthcare Providers and the authorized TessArray RM-Flu Fact Sheet for Patients.

    D. TessArae, LLC will inform state and/or local public health authority(ies) of this EUA, including the terms and conditions herein.

    E. All advertising and promotional descriptive printed matter relating to the use of the authorized TessArray RM-Flu shall be consistent with the Fact Sheets and authorized labeling, as
     well as the terms set forth in this EUA and other requirements set forth in the Act and FDA regulations.

    F. All advertising and promotional descriptive printed matter relating to the use of the authorized TessArray RM-Flu shall clearly and conspicuously state that:

       This test has not been FDA cleared or approved;

       This test has been authorized by FDA under an Emergency Use Authorization;

       This test has been authorized only for the detection of 2009 H1N1 influenza virus and not for any other viruses or pathogens;

       This test is only authorized for the duration of the declaration of emergency under section 564(b)(1) of the Act, 21 U.S.C. Sec.  360bbb-3(b)(1); and

       The declaration of emergency will expire on April 26, 2010, unless it is terminated or revoked sooner or renewed.

    G. No advertising or promotional descriptive printed matter relating to the use of the authorized TessArray RM-Flu may represent or suggest that this test is safe or effective for the
     diagnosis of 2009 H1N1 influenza virus.

    H. TessArae, LLC will ensure that CLIA High Complexity Laboratories using the authorized TessArray RM-Flu have a process in place for reporting test results to healthcare providers and
     federal, state and/or local public health authorities, as appropriate.

    I. TessArae, LLC will track adverse events and report to FDA as required under 21 CFR part 803.

    J. Through a process of inventory control, TessArae, LLC will maintain records of device usage.

    K. TessArae, LLC will collect information on the performance of the assay and report to FDA any suspected occurrence of false positive or false negative results of which TessArae, LLC
     becomes aware.

    L. TessArae, LLC is authorized to make available additional information relating to the emergency use of the authorized TessArray RM-Flu that is consistent with, and does not exceed, the
     terms of this letter of authorization.

    M. Only TessArae, LLC may request changes to the authorized TessArray RM-Flu Fact Sheet for Healthcare Providers or the authorized TessArray RM-Flu Fact Sheet for Patients. Such requests
     will be made by contacting FDA concerning FDA review and approval.

    CLIA High Complexity Laboratories

    N. CLIA High Complexity Laboratories will include with reports of the results of the TessArray RM-Flu the authorized Fact Sheet for Healthcare Providers and the authorized Fact Sheet for
     Patients.

    O. CLIA High Complexity Laboratories will use the EPICENTRE Masterpure\TM\ Complete DNA and RNA Purification Kit for nucleic acid extraction and perform the assay on the Affymetrix[reg]
     GeneChip[reg] Microarray Instrumentation System, ensuring that at least once per day specimens are tested, a known sample (such as that of a seasonal influenza virus vaccine) is tested as
     a positive control for RNA extraction, and is processed through all subsequent protocol steps.

    P. CLIA High Complexity Laboratories will have a process in place for reporting test results to healthcare providers and federal, state and/or local public health authorities, as
     appropriate.

    Q. CLIA High Complexity Laboratories will collect information on the performance of the assay, and report to TessArae, LLC any suspected occurrence of false positive or false negative
     results of which CLIA High Complexity Laboratories become aware.

    R. CLIA High Complexity Laboratories will clearly and conspicuously state on reports of the results of the TessArray RM-Flu that this test is only authorized for the diagnosis of 2009 H1N1
     influenza virus and not for seasonal influenza A, B, or any other pathogen.

    TessArae, LLC and CLIA High Complexity Laboratories

    S. TessArae, LLC, and CLIA High Complexity Laboratories will ensure that any records associated with this EUA are maintained until notified by FDA. Such records will be made available to
     FDA for inspection upon request.

 The emergency use of the authorized TessArray RM-Flu test as described in this letter of authorization must comply with the conditions above and all other terms of this authorization.

 V. Duration of Authorization

 This EUA will be effective until the declaration of emergency is terminated under section 564(b)(2) of the Act or the EUA is revoked under section 564(g) of the Act.

                   Margaret A. Hamburg, M.D.
                   Commissioner of Food and Drugs

 \1\ Memorandum, Determination Pursuant to Sec.   564 of the Federal Food, Drug, and Cosmetic Act (April 26, 2009).
\2\ No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act.

    (10) The Authorization for the CDC Swine Influenza Virus Real-time
rRT-PCR Detection Panel issued on April 27, 2009, amended on May 2,
2009, and as amended again and reissued in its entirety on December 18,
2009, follows and provides an explanation of the reasons for its
issuance, as required by section 564(h)(1) of the act:

 Thomas R. Frieden, MD, MPH
 Director
 Centers for Disease Control and Prevention
 1600 Clifton Rd, MS D-14
 Atlanta, GA 30333

 Dear Dr. Frieden:

 On April 27, 2009, FDA issued a letter authorizing the emergency use of the Swine Influenza Virus Real-time RT-PCR Detection Panel (rRT-PCR Swine Flu Panel) assay for the presumptive
 diagnosis of 2009 H1N1 influenza virus infection, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. Sec.   360bbb-3) by public health and other
 qualified laboratories. On May 1, 2009, CDC submitted a request for an amendment to the Emergency Use Authorization.\1\ On August 31, 2009 CDC submitted a request for a second amendment\2\
 and on November 30, 2009 CDC submitted a request for a third amendment\3\ to the Emergency Use Authorization G090072. In response to those requests, the letter authorizing emergency use of
 the rRT-PCR Swine Flu Panel is being reissued in its entirety with the amendments, as requested by CDC.

 On April 26, 2009, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. Sec.   360bbb-3(b)(1)(C)), the Secretary of the Department of Health and Human Services (HHS) determined that there
 is a public health emergency under 42 U.S.C. Sec.   247d that affects, or has a significant potential to affect, national security, and that involves a specified biological, chemical,
 radiological, or nuclear agent or agents, or a specified disease or condition that may be attributable to such an agent or agents -- in this case, 2009 H1N1 influenza virus.\4\ Pursuant to
 section 564(b) of the Act (21 U.S.C. Sec.   360bbb-3(b)), and on the basis of such determination, the Secretary of HHS then declared an emergency justifying the authorization of the emergency
 use of certain in vitro diagnostics for the detection of 2009 H1N1 influenza virus, subject to the terms of any authorization issued under 21 U.S.C. Sec.   360bbb-3(a).

 Having concluded that the criteria for issuance of this authorization under section 564(c) of the Act (21 U.S.C. Sec.   360bbb-3(c)) are met, I am authorizing the emergency use of the Swine
 Influenza Virus Real-time RT-PCR Detection Panel (rRT-PCR Swine Flu Panel) (as described in the scope section of this letter (Section II)) for the diagnosis of 2009 H1N1 influenza virus
 infection in individuals with signs and symptoms of respiratory infection, subject to the terms of this authorization.

 I. Criteria for Issuance of Authorization

 I have concluded that the emergency use of the rRT-PCR Swine Flu Panel for the diagnosis of 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory infection
 meets the criteria for issuance of an authorization under section 564(c) of the Act, because I have concluded that:

    1. The 2009 H1N1 influenza virus can cause influenza, a serious or life threatening disease or condition to humans infected by this virus;

    2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that the rRT-PCR Swine Flu Panel may be effective for the diagnosis of 2009 H1N1 influenza
     virus infection, and that the known and potential benefits of the rRT-PCR Swine Flu Panel, when used in the diagnosis of 2009 H1N1influenza virus infection, outweigh the known and
     potential risks of such products; and

    3. There is no adequate, approved, and available alternative to the emergency use of the rRT-PCR Swine Flu Panel for the diagnosis of 2009 H1N1 influenza virus infection.\5\

 II. Scope of Authorization

 I have concluded, pursuant to section 564(d)(1) of the Act, that the scope of this authorization is limited to the use of the authorized rRT-PCR Swine Flu Panel for the diagnosis of 2009 H1N1
 influenza virus infection in individuals with signs and symptoms of respiratory infection.

 The Authorized rRT-PCR Swine Flu Panel:

 The Swine Influenza Virus Real-time RT-PCR Detection Panel is a panel of oligonucleotide primers and dual-labeled hydrolysis (Taqman[reg]) probes for use in the real-time RT-PCR assay on the
 Roche LightCycler[reg] 2.0, and the Applied Biosystems (ABI) 7500 Fast Dx Real-time PCR, and the RUO marketed 7500 Fast Real-time PCR instruments for the in vitro qualitative detection of
 2009 H1N1 influenza viral RNA in upper respiratory tract specimens (such as nasopharyngeal swabs (NPS), nasal swabs (NS), throat swabs (TS), dual NPS/TS swabs, or nasal aspirates (NA)) and
 the lower respiratory tract specimens (such as bronchoalveolar lavage (BAL), bronchial aspirate (BA); bronchial washes (BW), endotracheal aspirates (EA) and endotracheal wash (EW), tracheal
 aspirates (TA), and lung tissue) from patients with signs and symptoms of respiratory infection and from viral culture. The universal influenza A (Matrix gene), 2009 H1N1 influenza swInfA (NP
 gene), and swH1 (HA gene) primer and probe sets are designed for detection of 2009 H1N1 influenza viruses.

 The rRT-PCR Swine Flu Panel includes the following primer and probe sets:
     InfA detects a well-conserved region of the Matrix Protein (M) gene from influenza A viruses in both seasonal human influenza A virus and 2009 H1N1 virus.
     swInfA specifically detects the 2009 H1N1 influenza strains (NP gene).
     swH1 is specific for the 2009 H1N1 influenza and detects the presence of the hemagglutinin (HA) gene specifically found in the 2009 H1N1 virus.

 The rRT-PCR Swine Flu Panel also includes control materials:
     RNase P (RP) detects human RNase P and is used as a positive control with human clinical specimens to indicate that adequate isolation of nucleic acid resulted from the extraction
     of the clinical specimen.
     Swine Influenza Panel Real-Time RT-PCR Positive Control (SIPC) is a positive control designed to react with all the primer and probe sets including RNase P.

 The above rRT-PCR Swine Flu Panel, when labeled consistently with the labeling authorized by FDA, entitled the Swine Influenza Virus Real-time RT-PCR Detection Panel (rRT-PCR Swine Flu Panel)
 (see http://www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161496.htm), as may be revised with written permission of FDA, is authorized to be distributed to public health and other
 qualified laboratories\6\ under this EUA, despite the fact that it does not meet certain requirements otherwise required by federal law.

 The above described rRT-PCR Swine Flu Panel is authorized to be accompanied by the following information pertaining to the emergency use, which are authorized to be made available to health
 care providers and patients:

     Fact Sheet For Healthcare Providers: Interpreting the Swine Influenza Virus Real-time RT-PCR Detection Panel Test Results

     Fact Sheet For Patients: Understanding rRT-PCR Swine Influenza Detection Panel Test Results

 As described in section IV below, CDC and the appropriate state and/or local public health authority(ies) are also authorized to make available additional information relating to the
 emergency use of the authorized rRT-PCR Swine Flu Panel that is consistent with, and does not exceed, the terms of this letter of authorization.

 I have concluded, pursuant to section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of the authorized rRT-PCR Swine Flu Panel in the specified
 population, when used for diagnosis of 2009 H1N1 influenza virus infection, outweigh the known and potential risks of such product.

 I have concluded, pursuant to section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that the authorized rRT-PCR Swine
 Flu Panel may be effective in the diagnosis of 2009 H1N1 influenza virus infection pursuant to section 564(c)(2)(A) of the Act. The FDA has reviewed the scientific information available
 including the information supporting the conclusions described in Section I above, and concludes that the authorized rRT-PCR Swine Flu Panel, when used to diagnose 2009 H1N1 influenza virus
 infection in the specified population, meets the criteria set forth in section 564(c) of the Act concerning safety and potential effectiveness.

 The emergency use of the authorized rRT-PCR Swine Flu Panel under this EUA must be consistent with, and may not exceed, the terms of this letter, including the scope and the conditions of
 authorization set forth below. Subject to the terms of this EUA and under the circumstances set forth in the Secretary of HHS' determination under section 564(b)(1)(C) described above and the
 Secretary of HHS' corresponding declaration under section 564(b)(1), the rRT-PCR Swine Flu Panel described above is authorized to diagnose 2009 H1N1 influenza virus infection in individuals
 with signs and symptoms of respiratory infection.

 This EUA will cease to be effective when the declaration of emergency is terminated under section 564(b)(2) of the Act or when the EUA is revoked under section 564(g) of the Act.

 III. Waiver of Certain Requirements

 I am waiving the following requirements for the rRT-PCR Swine Flu Panel during the duration of this emergency use authorization:

     Current good manufacturing practice requirements, including the quality system requirements under 21 CFR Part 820 with respect to the design, manufacture, packaging, labeling,
     storage, and distribution of the rRT-PCR Swine Flu Panel;

     Labeling requirements for cleared, approved, or investigational devices, including labeling requirements under 21 CFR 809.10 and 809.30, except for the intended use statement (21
     CFR 809.10(a)(2), (b)(2)), adequate directions for use (21 U.S.C. 352(f)), (21 CFR 809.10(b)(5) and (8)), any appropriate limitations on the use of the device including information
     required under 21 CFR 809.10(a)(4), and any available information regarding performance of the device, including requirements under 21 CFR 809.10(b)(12);

 IV. Conditions of Authorization

 Pursuant to section 564 of the Act, I am establishing the following conditions on this authorization:

 CDC

  A. CDC will distribute the rRT-PCR Swine Flu Panel with the authorized labeling, as may be revised with written permission of FDA only to qualified laboratories.

  B. CDC will provide to the qualified laboratories and state and/or local public health authority(ies) the authorized rRT-PCR Swine Flu Panel Fact Sheets for Health Care Providers, and the
   authorized rRT-PCR Swine Flu Panel Fact Sheets for Patients.

  C. CDC will make available on its website the authorized rRT-PCR Swine Flu Panel Fact Sheets for Health Care Providers, and the authorized rRT-PCR Swine Flu Panel Fact Sheets for Patients.

  D. CDC will inform state and/or local public health authority(ies) of this EUA, including the terms and conditions herein.

  E. CDC will ensure that qualified laboratories using the rRT-PCR Swine Flu Panel have a process in place for reporting test results to health care providers and federal, state and/or local
   public health authorities, as appropriate.

  F. CDC will track adverse events and report to FDA as required under 21 CFR part 803.

  G. Through a process of inventory control, CDC will maintain records of device usage.

  H. CDC will collect information on the performance of the assay, and report to FDA any suspected occurrence of false positive and negative results of which CDC becomes aware.

 Public Health and Other Qualified Laboratories

  I. Public health and other qualified laboratories will include with reports of the results of the rRT-PCR Swine Flu Panel, the authorized Fact Sheets for Health Care Providers and the
   authorized Fact Sheet for Patients.

  J. Qualified laboratories will perform the assay on the Roche LightCycler[reg] 2.0 Real-time PCR system, or an Applied Biosystems 7500 Fast Dx Real-time PCR instrument, or the RUO marketed
   Applied Biosystems 7500 Real-time PCR instrument that is validated by Applied Biosystems with regard to the updated software but only partially qualified regarding its laboratory
   performance (proficiency testing with the CDC sample panel not performed).

  K. Qualified laboratories will have a process in place for reporting test results to health care providers and federal, state and/or local public health authorities, as appropriate.

  L. Qualified laboratories will collect information on the performance of the assay, and report to CDC any suspected occurrence of false positive or false negative results of which qualified
   laboratories become aware.

 CDC and State and/or Local Public Health Authority(ies)

  M. CDC and the appropriate state and/or local public health authority(ies) are authorized to make available additional information relating to the emergency use of the authorized rRT-PCR
   Swine Flu Panel that is consistent with, and does not exceed, the terms of this letter of authorization.

  N. Only CDC may request changes to the authorized Fact Sheet for Health Care Providers or the authorized rRT-PCR Swine Flu Panel Fact Sheet for Patients. Such requests will be made by
   contacting FDA concerning FDA review and approval.

  O. CDC and the appropriate state/and or local public health authority(ies) will ensure that any records associated with this EUA are maintained until notified by FDA. Such records will be
   made available to FDA for inspection upon request.

 The emergency use of the authorized rRT-PCR Swine Flu Panel as described in this letter of authorization must comply with the conditions above and all other terms of this authorization.

 V. Duration of Authorization

 This EUA will be effective until the declaration of emergency is terminated under section 564(b)(2) of the Act or the EUA is revoked under section 564(g) of the Act.

                   Margaret A. Hamburg, M.D.
                   Commissioner of Food and Drugs

 \1\ The amendment to the April 27, 2009 letter allow use of different sample types (throat swabs (TS), dual NPS/TS swab, or nasal aspirate (NA) specimens) and different reagents.
\2\ The amendment to the May 2, 2009 letter allow use of the LightCycler[reg] 2.0 Real-time PCR system, in addition to the ABI 7500 Fast Dx system, with the CDC rRT-PCR Swine Flu Panel .
\3\ The amendment to the May 2, 2009 letter authorize use of nasal washes as additional upper respiratory tract specimen and use of lower respiratory tract specimens (such as bronchoalveolar
  lavage (BAL), bronchial aspirate (BA); bronchial wash (BW); endotracheal aspirate (EA); endotracheal wash (EW); tracheal aspirate (TA), and lung tissue) as acceptable clinical specimens with
  the CDC rRT-PCR Swine Flu Panel; to remove the word ``presumptive'' from the Intended Use; to allow the use of the CDC rRT-PCR Swine Flu Panel as a stand alone test; to include Human
  Specimen Control (HSC) that was previously included in the CDC rRT-PCR Flu Panel (IVD, K080570); and to update packaging by removing product from foam envelopes and segregating into boxes.
  There are also minor wording changes made to be consistent with more recently issued Emergency Use Authorizations for in vitro diagnostic devices.
\4\ Memorandum, Determination Pursuant to Sec.   564 of the Federal Food, Drug, and Cosmetic Act (April 26, 2009).
\5\ No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act.
\4\ All users, analysts, and any person reporting diagnostic results from use of this device should be trained to perform and interpret the results from this procedure by a CDC instructor or
  designee prior to use. CDC Influenza Division will limit the distribution of this device to those users who have successfully completed training provided by CDC instructors or designees. Use
  is limited to designated laboratories that are qualified to receive and use the CDC rRT-PCR Flu Panel (IVD) 510(K) 080570. See ``Conditions of Authorization'' below.

    (11) The Authorization for the Cepheid Xpert Flu A Panel issued on
December 24, 2009, follows and provides an explanation of the reasons
for its issuance, as required by section 564(h)(1) of the act:

 Russel K. Enns, Ph.D.
 Senior Vice President
 Regulatory, Clinical & Government Affairs and Quality Systems
 Cepheid
 904 Caribbean Drive
 Sunnyvale, CA 94089

 Dear Dr. Enns:

 This letter is in response to your request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for emergency use of the Cepheid Xpert[reg] Flu A Panel for
 the diagnosis of 2009 H1N1 influenza virus infection in patients with signs and symptoms of respiratory infection, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the
 Act) (21 U.S.C. Sec.  360bbb-3), by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. Sec.  263a, to perform moderate complexity tests and
 by laboratories certified under CLIA to perform high complexity tests.\1\

 On April 26, 2009, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. Sec.  360bbb-3(b)(1)(C)), the Secretary of the Department of Health and Human Services (HHS) determined that there is
 a public health emergency under 42 U.S.C. Sec.  247d that affects, or has a significant potential to affect, national security, and that involves a specified biological, chemical,
 radiological, or nuclear agent or agents, or a specified disease or condition that may be attributable to such an agent or agents - in this case, 2009 H1N1 influenza virus.\2\ Pursuant to
 section 564(b) of the Act (21 U.S.C. Sec.  360bbb-3(b)), and on the basis of such determination, the Secretary of HHS then declared an emergency justifying the authorization of the emergency
 use of certain in vitro diagnostics for the detection of 2009 H1N1 influenza virus, subject to the terms of any authorization issued under 21 U.S.C. Sec.  360bbb-3(a).

 Having concluded that the criteria for issuance of this authorization under section 564(c) of the Act (21 U.S.C. Sec.  360bbb-3(c)) are met, I am authorizing the emergency use of the
 Xpert[reg] Flu A Panel (as described in the scope section of this letter (Section II)) for the diagnosis of 2009 H1N1 influenza virus infection in individuals with signs and symptoms of
 respiratory infection, subject to the terms of this authorization.

 I. Criteria for Issuance of Authorization

 I have concluded that the emergency use of the Xpert[reg] Flu A Panel for the diagnosis of 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory infection
 meets the criteria for issuance of an authorization under section 564(c) of the Act, because I have concluded that:

    1. The 2009 H1N1 influenza virus can cause influenza, a serious or life threatening disease or condition to humans infected by this virus;

    2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that the Xpert[reg] Flu A Panel may be effective for the diagnosis of 2009 H1N1 influenza
     virus infection, and that the known and potential benefits of the Xpert[reg] Flu A Panel, when used in the diagnosis of 2009 H1N1 influenza virus infection, outweigh the known and
     potential risks of such product; and

    3. There is no adequate, approved, and available alternative to the emergency use of the Xpert[reg] Flu A Panel for the diagnosis of 2009 H1N1 influenza virus infection.\3\

 II. Scope of Authorization

 I have concluded, pursuant to section 564(d)(1) of the Act, that the scope of this authorization is limited to the use of the authorized Xpert[reg] Flu A Panel for the diagnosis of 2009 H1N1
 influenza virus infection in individuals with signs and symptoms of respiratory infection.

 The Authorized Xpert[reg] Flu A Panel:

 The Cepheid Xpert Flu A Panel is a rapid, automated in vitro diagnostic test for qualitative detection and differentiation of 2009 H1N1 influenza virus RNA. The assay is performed on the
 Cepheid GeneXpert Dx System. The system automates and integrates sample purification, nucleic acid amplification, and detection of the target viral RNA sequences using real-time reverse
 transcriptase polymerase chain reaction (rRT-PCR). The system consists of an instrument, personal computer, and preloaded software for running tests and viewing the results.

 The assay detects specific viral gene sequences for the Flu A matrix (Flu A target), and the hemagglutinin gene of 2009 H1N1 influenza virus (2009 H1N1 target). The specimen types for which
 analytical and method comparison in clinical samples performance data are provided include nasal aspirates/washes (NA/W) and nasopharyngeal (NP) swab specimens in viral transport media (VTM)
 or universal transport media (UTM) collected from patients suspected of having influenza.

 Components of the Test:
 The Xpert Flu A Panel includes the following assays:

     Flu A Matrix: four forward primer sequences, three reverse primers and one probe sequence for detecting the matrix gene in Flu A
     2009 H1: two forward primer sequences, one reverse primer and one probe sequence for detecting the hemagglutinin gene in 2009 Flu A H1.

 The Xpert Flu A Panel also includes the following controls:

     SPC: Armored RNA in the form of a dry bead that is included in each cartridge to verify adequate processing of the sample virus.
     PCC: The Probe Check Control PCC indicates that the probes and dyes are present and intact

 The Xpert Flu A Panel requires the following hardware with corresponding software:

     Cepheid GeneXpert Dx System and software package

 The above described Xpert Flu A Panel , when labeled consistently with the labeling authorized by FDA, entitled Xpert Flu A Panel Assay Package Insert, (available at http://www.fda.gov/
 MedicalDevices/Safety/EmergencySituations/ucm161496.htm), as may be revised with written permission of FDA, is authorized to be distributed to and used by CLIA Moderate and High Complexity
 Laboratories under this EUA, despite the fact that it does not meet certain requirements otherwise required by federal law.

 The above described Xpert[reg] Flu A Panel is authorized to be accompanied by the following information pertaining to the emergency use, which is authorized to be made available to healthcare
 providers and patients:

     Fact Sheet For Healthcare Providers: Interpreting Cepheid[reg] Xpert[reg] Flu A Panel Test Results

     Fact Sheet For Patients: Understanding Cepheid[reg] Xpert[reg] Flu A Panel Test Results

 As described in section IV below, Cepheid is also authorized to make available additional information relating to the emergency use of the authorized Xpert[reg] Flu A Panel that is consistent
 with, and does not exceed, the terms of this letter of authorization.

 I have concluded, pursuant to section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of the authorized Xpert[reg] Flu A Panel in the specified
 population, when used for diagnosis of 2009 H1N1 influenza virus infection, outweigh the known and potential risks of such a product.

 I have concluded, pursuant to section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that the authorized Xpert[reg] Flu
 A Panel may be effective in the diagnosis of 2009 H1N1 influenza virus infection pursuant to section 564(c)(2)(A) of the Act. The FDA has reviewed the scientific information available
 including the information supporting the conclusions described in Section I above, and concludes that the authorized Xpert[reg] Flu A Panel, when used to diagnose 2009 H1N1 influenza virus
 infection in the specified population, meets the criteria set forth in section 564(c) of the Act concerning safety and potential effectiveness.

 The emergency use of the authorized Xpert[reg] Flu A Panel under this EUA must be consistent with, and may not exceed, the terms of this letter, including the scope and the conditions of
 authorization set forth below. Subject to the terms of this EUA and under the circumstances set forth in the Secretary of HHS's determination under section 564(b)(1)(C) described above and
 the Secretary of HHS's corresponding declaration under section 564(b)(1), the Xpert[reg] Flu A Panel described above is authorized to diagnose 2009 H1N1 influenza virus infection in
 individuals with signs and symptoms of respiratory infection.

 This EUA will cease to be effective when the declaration of emergency is terminated under section 564(b)(2) of the Act or when the EUA is revoked under section 564(g) of the Act.

 III. Waiver of Certain Requirements

 I am waiving the following requirements for the Xpert[reg] Flu A Panel during the duration of this emergency use authorization:

     Current good manufacturing practice requirements, including the quality system requirements under 21 CFR Part 820 with respect to the design, manufacture, packaging, labeling,
     storage, and distribution of the Xpert[reg] Flu A Panel.

     Labeling requirements for cleared, approved, or investigational devices, including labeling requirements under 21 CFR 809.10 and 809.30, except for the intended use statement (21
     CFR 809.10(a)(2), (b)(2)), adequate directions for use (21 U.S.C. 352(f)), (21 CFR 809.10(b)(5) and (8)), any appropriate limitations on the use of the device including information
     required under 21 CFR 809.10(a)(4), and any available information regarding performance of the device, including requirements under 21 CFR 809.10(b)(12).

 IV. Conditions of Authorization

 Pursuant to section 564 of the Act, I am establishing the following conditions on this authorization:

    Cepheid

    A. Cepheid will distribute the authorized Xpert[reg] Flu A Panel with the authorized labeling, as may be revised with written permission of FDA, only to CLIA Moderate and High Complexity
     Laboratories.

    B. Cepheid will provide to the CLIA Moderate and High Complexity Laboratories the authorized Xpert[reg] Flu A Panel Fact Sheet for Healthcare Providers and the authorized Xpert[reg] Flu A
     Panel Fact Sheet for Patients.

    C. Cepheid will make available on its website the authorized Xpert[reg] Flu A Panel Fact Sheet for Healthcare Providers and the authorized Xpert[reg] Flu A Panel Fact Sheet for Patients.

    D. Cepheid will inform state and/or local public health authority(ies) of this EUA, including the terms and conditions herein.

    E. All advertising and promotional descriptive printed matter relating to the use of the authorized Xpert[reg] Flu A Panel shall be consistent with the Fact Sheets and authorized labeling,
     as well as the terms set forth in this EUA and other requirements set forth in the Act and FDA regulations.

    F. All advertising and promotional descriptive printed matter relating to the use of the authorized Xpert[reg] Flu A Panel shall clearly and conspicuously state that:

       This test has not been FDA cleared or approved;

       FDA has not determined that this test may be performed in settings with certificates of waiver under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C.
       Sec.   263a;

       This test has been authorized by FDA under an Emergency Use Authorization;

       This test has been authorized only for the detection of 2009 H1N1 influenza virus and not for any other viruses or pathogens;

       This test is only authorized for the duration of the declaration of emergency under section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. Sec.   360bbb-
       3(b)(1), unless the authorization is revoked sooner; and

       The declaration of emergency will expire on April 26, 2010, unless it is terminated sooner or renewed.

    G. No advertising or promotional descriptive printed matter relating to the use of the authorized Xpert[reg] Flu A Panel may represent or suggest that this test is safe or effective for
     the diagnosis of 2009 H1N1 influenza virus.

    H. Cepheid will ensure that CLIA Moderate and High Complexity Laboratories using the authorized Xpert[reg] Flu A Panel have a process in place for reporting test results to healthcare
     providers and federal, state and/or local public health authorities, as appropriate.

    I. Cepheid will track adverse events and report to FDA as required under 21 CFR part 803.

    J. Through a process of inventory control, Cepheid will maintain records of device usage.

    K. Cepheid will collect information on the performance of the assay and report to FDA any suspected occurrence of false positive or false negative results of which Cepheid becomes aware.

    L. Cepheid is authorized to make available additional information relating to the emergency use of the authorized Xpert[reg] Flu A Panel that is consistent with, and does not exceed, the
     terms of this letter of authorization.

    M. Only Cepheid may request changes to the authorized Xpert[reg] Flu A Panel Fact Sheet for Healthcare Providers or the authorized Xpert[reg] Flu A Panel Fact Sheet for Patients. Such
     requests will be made by contacting FDA concerning FDA review and approval.

    CLIA Moderate and High Complexity Laboratories

    N. CLIA Moderate and High Complexity Laboratories will include with reports of the results of the Xpert[reg] Flu A Panel the authorized Fact Sheet for Healthcare Providers and the
     authorized Fact Sheet for Patients.

    O. CLIA Moderate and High Complexity Laboratories will perform the assay on the Cepheid GeneXpert Dx System.

    P. CLIA Moderate and High Complexity Laboratories will have a process in place for reporting test results to healthcare providers and federal, state and/or local public health authorities,
     as appropriate.

    Q. CLIA Moderate and High Complexity Laboratories will collect information on the performance of the assay, and report to Cepheid any suspected occurrence of false positive or false
     negative results of which CLIA Moderate and High Complexity Laboratories become aware.

    R. CLIA Moderate and High Complexity Laboratories will clearly and conspicuously state on reports of the results of the Xpert Flu A that this test is only authorized for the diagnosis of
     2009 H1N1 influenza virus and not for seasonal influenza A, B, or any other pathogen.

    Cepheid and CLIA Moderate and High Complexity Laboratories

    S. Cepheid and CLIA Moderate and High Complexity Laboratories will ensure that any records associated with this EUA are maintained until notified by FDA. Such records will be made
     available to FDA for inspection upon request.

 The emergency use of the authorized Xpert[reg] Flu A Panel as described in this letter of authorization must comply with the conditions above and all other terms of this authorization.

 V. Duration of Authorization

 This EUA will be effective until the declaration of emergency is terminated under section 564(b)(2) of the Act or the EUA is revoked under section 564(g) of the Act.

                   Joshua M. Sharfstein, M.D.
                   Principal Deputy Commissioner of Food and Drugs

 \1\ For ease of reference this letter will refer to these two types of laboratories together as ``CLIA Moderate and High Complexity Laboratories.''
\2\ Memorandum, Determination Pursuant to Sec.   564 of the Federal Food, Drug, and Cosmetic Act (April 26, 2009).
\3\ No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act.

    Dated: April 9, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-8605 Filed 4-16-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 81, Number 70 (Tuesday, April 12, 2016)]
[Notices]
[Pages 21644-21645]
[FR Doc No: 2016-08314]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2016-36]

Petition for Exemption; Summary of Petition Received; Martin UAV

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of title 14 of the Code of Federal
Regulations. The purpose of this notice is to improve the public's
awareness of, and participation in, the FAA's exemption process.
Neither publication of this notice nor the inclusion or omission of
information in the summary is intended to affect the legal status of
the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before May 2, 2016.

ADDRESSES: Send comments identified by docket number FAA-2015-5644
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to http://www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
http://www.dot.gov/privacy.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Dan Ngo,<PHONE_NUMBER>. 800
Independence Avenue SW., Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC.
James M. Crotty,
Acting Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2015-5644.
    Petitioner: Martin UAV.
    Section(s) of 14 CFR Affected: Part 21, Subpart H; Sec. Sec.
45.23(b); 45.27(a); 61.113; 91.7(a); 91.9(b)(2); 91.9(c);
91.103(b)(2);; 91.109(a); 91.119(c); 91.121; 91.151(a); 91.203 (a) &
(b); 91.405(a); 91.407(a)(1); 91.409(a)(1) & (2); 91.417 (a) & (b).
    Description of Relief Sought: The petitioner is requesting relief
to conduct commercial operations, including

training, with the Bat 4 and V-Bat, both of which are heavier than 55
pounds, as well as the SuperBat.

[FR Doc. 2016-08314 Filed 4-11-16; 8:45 am]
BILLING CODE 4910-13-P