Source: http://www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm200976.htm
Timestamp: 2016-07-30 22:48:14
Document Index: 36110848

Matched Legal Cases: ['§360', '§263', '§360', 'art 820', '§ 360', 'art 803']

Letter of Authorization: Diagnostic Hybrids, Inc. D3 Ultra 2009 H1N1 Influenza A Virus ID Kit Skip to main page content
Letter of Authorization: Diagnostic Hybrids, Inc. D3 Ultra 2009 H1N1 Influenza A Virus ID Kit
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.
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.
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
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
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.
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.
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
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.
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.
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.
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.
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
Diagnostic Hybrids, Inc. will inform state and/or local public health authority(ies) of this EUA, including the terms and conditions herein.
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.
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 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.
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.
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.
Diagnostic Hybrids, Inc. will track adverse events and report to FDA as required under 21 CFR part 803.
Through a process of inventory control, Diagnostic Hybrids, Inc. will maintain records of device usage.
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.
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.
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.
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 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.
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.
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.
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.
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.
Dr. Margaret A. Hamburg,
2 No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act. More in Emergency Situations (Medical Devices)