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U.S. Department of Health and Human Services

Medical Devices

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Letter of Authorization: Diagnostic Hybrids, Inc. D3 Ultra 2009 H1N1 Influenza A Virus ID Kit

The information previously contained on these webpages were authorized under the 2009 H1N1 Influenza Emergency Use Authorizations (EUAs). As of June 23, 2010, the EUAs have been terminated and this information is no longer current.

February 16, 2010

Ronald H. Lollar
Senior Director Product Realization
Management and Marketing
Diagnostic Hybrids, Inc.
1055 East State Street
Suite 100
Athens, OH 45701

Dear Mr. Lollar:

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 Diagnostic Hybrids, Inc. D3 Ultra 2009 H1N1 Influenza A Virus ID Kit for the detection of 2009 H1N1 influenza A viral antigens present in infected cells directly from nasal and nasopharyngeal swabs and aspirates/washes specimens or cell culture from individuals with signs and symptoms of respiratory infection who have previously tested positive for the presence of influenza A virus-infected cells by a currently available FDA-cleared direct immunofluorescence influenza A antibody device pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3), by CLIA high complexity laboratories, which are laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a.

On April 26, 2009, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. §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. §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. §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. §360bbb-3(a).

Having concluded that the criteria for issuance of this authorization under section 564(c) of the Act (21 U.S.C. §360bbb-3(c)) are met, I am authorizing the emergency use of the Diagnostic Hybrids D3 Ultra 2009 H1N1 Influenza A Virus ID Kit (as described in the scope section of this letter (Section II)) for the detection of 2009 H1N1 influenza A viral antigens present in infected cells directly from nasal and nasopharyngeal swabs and aspirates/washes specimens or cell culture from individuals with signs and symptoms of respiratory infection who have previously tested positive for the presence of influenza A virus-infected cells by a currently available FDA-cleared direct immunofluorescence influenza A antibody device subject to the terms of this authorization.

I. Criteria for Issuance of Authorization

I have concluded that the emergency use of the Diagnostic Hybrids D3 Ultra 2009 H1N1 Influenza A Virus ID Kit for the detection of 2009 H1N1 influenza A viral antigens present in infected cells directly from nasal and nasopharyngeal swabs and aspirates/washes specimens or cell culture from individuals with signs and symptoms of respiratory infection who have previously tested positive for the presence of influenza A virus-infected cells by a currently available FDA-cleared direct immunofluorescence influenza A antibody device 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 Diagnostic Hybrids D3 Ultra 2009 H1N1 Influenza A Virus ID Kit may be effective for the diagnosis of 2009 H1N1 influenza virus infection, and that the known and potential benefits of the Diagnostic Hybrids D3 Ultra 2009 H1N1 Influenza A Virus ID Kit , 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 Diagnostic Hybrids D3 Ultra 2009 H1N1 Influenza A Virus ID Kit 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 Diagnostic Hybrids D3 Ultra 2009 H1N1 Influenza A Virus ID Kit for detection of 2009 H1N1 influenza A viral antigens present in infected cells directly from nasal and nasopharyngeal swabs and aspirates/washes specimens or cell culture from individuals with signs and symptoms of respiratory infection who have previously tested positive for the presence of influenza A virus-infected cells by a currently available FDA-cleared direct immunofluorescence influenza A antibody device

The Authorized Diagnostic Hybrids D3 Ultra 2009 H1N1 Influenza A Virus ID Kit:

The Diagnostic Hybrids D3 Ultra 2009 H1N1 Influenza A Virus ID Kit uses a blend of 2009 H1 influenza antigen-specific murine monoclonal antibodies that when combined with a fluorescein-labeled conjugate is intended for the detection of 2009 H1N1 Influenza A Virus antigens present in infected cells directly from nasal and nasopharyngeal swabs and aspirates/washes specimens or cell culture from individuals with signs and symptoms of respiratory infection who have previously tested positive for the presence of influenza A virus-infected cells by a currently available FDA-cleared direct immunofluorescence influenza A antibody device.

Components of the Test:

The Diagnostic Hybrids D3 Ultra 2009 H1N1 Influenza A Virus ID Kit includes the following components:

  • D3 Ultra 2009 Flu-A ID R eagent , 5.0-mL. One dropper bottle containing a mixture of murine monoclonal antibodies directed against 2009 H1 influenza A virus antigen. The buffered, stabilized, aqueous solution contains 0.1% sodium azide as preservative.
  • D 3 Flu-A ID Conjugate, 5.0-mL. An aqueous, stabilized, buffered solution containing fluorescein-labeled, affinity purified goat-anti-mouse IgG antibody and Evans Blue with sodium azide as preservative.
  • 40X PBS Concentrate, 25-mL. One bottle of 40X PBS concentrate containing 4% sodium azide (0.1% sodium azide after dilution to 1X using de-mineralized water).
  • Mounting Fluid, 7-mL. One dropper bottle containing an aqueous, buffer-stabilized solution of glycerol with 0.1% sodium azide.

The Diagnostic Hybrids D3 Ultra 2009 H1N1 Influenza A Virus ID Kit also includes the following control materials:

  • D3 Ultra 2009 H1N1 Influenza A Virus ID Antigen Control Slides, 5-slides. Five (5) individually packaged control slides containing 2 wells with cell culture-derived positive and negative control cells.
  • The positive well contains cells infected with 2009 H1N1 influenza A virus.
  • The negative wells contain non-infected cells. Each slide is intended to be stained only one time.

The above described Diagnostic Hybrids D3 Ultra 2009 H1N1 Influenza A Virus ID Kit, when labeled consistently with the labeling authorized by FDA, entitled D3 Ultra 2009 H1N1 Influenza A Virus ID Kit 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 Diagnostic Hybrids D3 Ultra 2009 H1N1 Influenza A Virus ID Kit 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 the D3 Ultra 2009 H1N1 Influenza A Virus ID Kit Test Results
  • Fact Sheet For Patients: Understanding the D3 Ultra 2009 H1N1 Influenza A Virus ID Kit Test Results

As described in section IV below, Diagnostic Hybrids, Inc. is also authorized to make available additional information relating to the emergency use of the authorized Diagnostic Hybrids D3 Ultra 2009 H1N1 Influenza A Virus ID Kit 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 Diagnostic Hybrids D3 Ultra 2009 H1N1 Influenza A Virus ID Kit 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 Diagnostic Hybrids D3 Ultra 2009 H1N1 Influenza A Virus ID Kit 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 Diagnostic Hybrids D3 Ultra 2009 H1N1 Influenza A Virus ID Kit, 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 Diagnostic Hybrids D3 Ultra 2009 H1N1 Influenza A Virus ID Kit 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 Diagnostic Hybrids D3 Ultra 2009 H1N1 Influenza A Virus ID Kit described above is authorized to diagnose 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory infection who previously tested positive for the presence of influenza A virus-infected cells by a currently available FDA-cleared direct immunofluorescence influenza A antibody device.

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 Diagnostic Hybrids D3 Ultra 2009 H1N1 Influenza A Virus ID Kit 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 Diagnostic Hybrids D3 Ultra 2009 H1N1 Influenza A Virus ID Kit.
  • 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:

Diagnostic Hybrids, Inc.

  1. Diagnostic Hybrids, Inc. will distribute the authorized D3 Ultra 2009 H1N1 Influenza A Virus ID Kit with the authorized labeling, as may be revised with written permission of FDA, only to CLIA High Complexity Laboratories.
  2. Diagnostic Hybrids, Inc. will provide to the CLIA High Complexity Laboratories the authorized D3 Ultra 2009 H1N1 Influenza A Virus ID Kit Fact Sheet for Healthcare Providers and the authorized D3 Ultra 2009 H1N1 Influenza A Virus ID Kit Fact Sheet for Patients.
  3. Diagnostic Hybrids, Inc. will make available on its website the authorized D3 Ultra 2009 H1N1 Influenza A Virus ID Kit Fact Sheet for Healthcare Providers and the authorized D3 Ultra 2009 H1N1 Influenza A Virus ID Kit Fact Sheet for Patients.
  4. Diagnostic Hybrids, Inc. will clearly and conspicuously state on reports of the results of the D3 Ultra 2009 H1N1 Influenza A Virus ID Kit that this test is only authorized for the diagnosis of 2009 H1N1 influenza virus and not for seasonal influenza A, B, or any other virus or pathogen
  5. Diagnostic Hybrids, Inc. will inform state and/or local public health authority(ies) of this EUA, including the terms and conditions herein.
  6. All advertising and promotional descriptive printed matter relating to the use of the authorized D3 Ultra 2009 H1N1 Influenza A Virus ID Kit 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.
  7. All advertising and promotional descriptive printed matter relating to the use of the authorized D3 Ultra 2009 H1N1 Influenza A Virus ID Kit 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 Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1); and
    • The declaration of emergency will expire on April 26, 2010, unless it is terminated sooner or renewed.
  8. No advertising or promotional descriptive printed matter relating to the use of the authorized Diagnostic Hybrids D3 Ultra 2009 H1N1 Influenza A Virus ID Kit may represent or suggest that this test is safe or effective for the diagnosis of 2009 H1N1 influenza virus.
  9. Diagnostic Hybrids, Inc. will ensure that CLIA High Complexity Laboratories using the authorized D3 Ultra 2009 H1N1 Influenza A Virus ID Kit have a process in place for reporting test results to healthcare providers and federal, state and/or local public health authorities, as appropriate.
  10. Diagnostic Hybrids, Inc. will track adverse events and report to FDA as required under 21 CFR part 803.
  11. Through a process of inventory control, Diagnostic Hybrids, Inc. will maintain records of device usage.
  12. Diagnostic Hybrids, Inc. 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 Diagnostic Hybrids, Inc. becomes aware.
  13. Diagnostic Hybrids, Inc. is authorized to make available additional information relating to the emergency use of the authorized D 3 H1N1 Influenza A Virus ID Kit that is consistent with, and does not exceed, the terms of this letter of authorization.
  14. Only Diagnostic Hybrids, Inc. may request changes to the authorized D 3 2009 H1N1 Influenza A Virus ID Kit Fact Sheet for Healthcare Providers or the authorized D 3 2009 H1N1 Influenza A Virus ID Kit for Patients. Such requests will be made by contacting FDA concerning FDA review and approval.
  15. Diagnostic Hybrids, Inc. 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.

CLIA High Complexity Laboratories

  1. CLIA High Complexity Laboratories will test a patient sample using the Diagnostic Hybrids D3 Ultra 2009 H1N1 Influenza A Virus ID Kit only when the patient sample has already tested positive for the presence of influenza A virus-infected cells by a currently available FDA-cleared direct immunofluorescence antibody influenza A device.
  2. CLIA High Complexity Laboratories will include with reports of the results of the Diagnostic Hybrids D 3 2009 H1N1 Influenza A Virus ID Kit the authorized Fact Sheet for Healthcare Providers and the authorized Fact Sheet for Patients.
  3. 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.
  4. CLIA High Complexity Laboratories will collect information on the performance of the assay, and report to Diagnostic Hybrids, Inc. any suspected occurrence of false positive or false negative results of which CLIA High Complexity Laboratories become aware.
  5. CLIA High Complexity Laboratories will clearly and conspicuously state on reports of the results of the Diagnostic Hybrids D 3 2009 H1N1 Influenza A Virus ID Kit 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.
  6. Diagnostic Hybrids, Inc. 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 Diagnostic Hybrids D3 Ultra 2009 H1N1 Influenza A Virus ID Kit 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.

Dr. Margaret A. Hamburg,
Commissioner of Food and Drugs Administration


1 Memorandum, Determination Pursuant to § 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.