Source: http://www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm194978.htm
Timestamp: 2016-08-27 18:45:40
Document Index: 173892878

Matched Legal Cases: ['§360', '§263', '§360', 'art 820', 'art 803', '§ 564']

Letter of Authorization: TessArray Resequencing Influenza A Microarray Detection Panel Skip to main page content
Letter of Authorization: TessArray Resequencing Influenza A Microarray Detection Panel
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. §360bbb-3) for emergency use of the TessArray® 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. §263a, to perform high complexity tests.
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 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 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:
The 2009 H1N1 influenza virus can cause influenza, a serious or life threatening disease or condition to humans infected by this virus.
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
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]
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 MasterpureTM Complete DNA and RNA Purification Kit and the Affymetrix® GeneChip® 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:
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
HA1hu a representative hemagglutinin gene sequence from A/H1N
NA1hu a representative neuraminidase gene sequence from A/H1N1
HA3hu a representative hemagglutinin gene sequence from A/H1N1
NA2hu a representative neuraminidase gene sequence from A/H1N1
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 Peltier DNA Engine Tetrad
Affymetrix® GeneChip® 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® Biotechnologies MasterpureTMComplete DNA and RNA Purification Kit
Life Technologies™ Superscript™ III Reverse Transcriptase
Life Technologies™ RNaseOUTTM Recombinant Ribonuclease Inhibitor
Promega®, GoTaq® Flexi DNA Polymerase
USB (Affymetrix®) Uracil-DNA Glycosylase (UDG), Heat-Labile
Qiagen® QIAquick® PCR Purification Kit
Affymetrix® GeneChip® 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:
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.
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.
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:
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.
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 MasterpureTM Complete DNA and RNA Purification Kit for nucleic acid extraction and perform the assay on the Affymetrix® GeneChip® 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.
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.
[1] Memorandum, Determination Pursuant to § 564 of the Federal Food, Drug, and Cosmetic Act (April 26, 2009).