CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/H5 SUBTYPING

K141859 · Centers for Disease Control and Prevention · OZE · Aug 1, 2014 · Microbiology

Device Facts

• Record ID: K141859
• Device Name: CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/H5 SUBTYPING
• Applicant: Centers for Disease Control and Prevention
• Product Code: OZE · Microbiology
• Decision Date: Aug 1, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3980
• Device Class: Class 2

Indications for Use

The Influenza A/H5 Subtyping Kit contains reagents and controls of the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel and is intended for use in real-time RT-PCR (rRT-PCR) assays on an Applied Biosystems (ABI) 7500 Fast Dx Real-Time PCR instrument in conjunction with clinical and epidemiological information: For the presumptive identification of virus in patients who may be infected with influenza A subtype A/H5(Asian Lineage) from viral RNA in human respiratory specimens and viral culture in conjunction with clinical and epidemiological risk factors; To provide epidemiologic information for surveillance of circulating influenza viruses. Performance characteristics for influenza were established during a season when seasonal influenza viruses A/H1 and A/H3 were the predominant influenza A viruses in circulation and during a season when the A/H1pdm09 influenza virus was the predominant influenza A virus in circulation. Performance characteristics may vary with other emerging influenza A viruses. Testing with the influenza H5a and H5b primer and probe sets should not be performed unless the patient meets the most current U.S. Department of Health and Human Services (DHHS) clinical and epidemiological criteria for testing suspect A/H5 specimens. The definitive identification of influenza A/H5 (Asian lineage) either directly from patient specimens or from virus cultures requires additional laboratory testing, along with clinical and epidemiological assessment in consultation with national influenza surveillance experts. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Conversely, positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted unless a BSL 3+ facility is available to receive and culture specimens. All users, analysts, and any person reporting results from use of this device should be trained to perform and interpret the results from this procedure by a competent instructor prior to use. CDC Influenza Division will limit the distribution of this device to only those users who have successfully completed a training course provided by CDC instructors or designees.

Device Story

Real-time RT-PCR diagnostic panel; detects and characterizes human influenza viruses in respiratory specimens. Modification allows Influenza A/H5 Subtyping Kit to be provided as a separate component from other panel kits (Influenza A/B Typing, Influenza A Subtyping, Influenza B Lineage Genotyping) to manage reagent supply and minimize waste. No changes to fundamental scientific technology, physical characteristics, or intended use. Used by trained laboratory personnel in clinical settings for diagnostic aid and epidemiological surveillance.

Clinical Evidence

No clinical data; bench testing only. Substantial equivalence based on design control activities and risk analysis confirming labeling modifications do not affect device performance or intended use.

Technological Characteristics

Real-time RT-PCR assay; uses oligonucleotide primers and dual-labeled hydrolysis (TaqMan) probes. Instrumentation: Applied Biosystems 7500 Fast Dx Real-Time PCR. Nucleic acid extraction required. Qualitative detection of viral RNA.

Indications for Use

Indicated for qualitative detection and characterization of human influenza viruses in respiratory specimens to aid diagnosis and provide epidemiological surveillance.

Regulatory Classification

Identification

A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection when used in conjunction with other clinical and laboratory findings. The device is intended for detection and identification of a combination of the following viruses:(1) Influenza A and Influenza B; (2) Influenza A subtype H1 and Influenza A subtype H3; (3) Respiratory Syncytial Virus subtype A and Respiratory Syncytial Virus subtype B; (4) Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus; (5) Human Metapneumovirus; (6) Rhinovirus; and (7) Adenovirus.

Special Controls

*Classification.* Class II (special controls). The special controls are:(1) FDA's guidance document entitled “Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay;” (2) For a device that detects and identifies Human Metapneumovirus, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays;” and (3) For a device that detects and differentiates Influenza A subtype H1 and subtype H3, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Nucleic Acid Assays.” See § 866.1(e) for the availability of these guidance documents.

Predicate Devices

• CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (K132508)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIR Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K141859

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device.
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel 510(k) number: K132508

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

3. A description of the device MODIFICATION(S):
This change was for a revision of the package insert for the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel. Recently, additional assays have been included in the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel and cleared by FDA to accommodate the new influenza virus subtypes. The consumption of the various assays within the panel may be different since the prevalence of influenza virus types and subtypes vary from season to season. To address the variation in consumption, CDC will provide the users with an option to order different configurations of specific components of the panel to manage the supply of reagents more efficiently minimizing waste. The package insert was modified by removing information not related to the Influenza A/H5 Subtyping Kit. This modification will allow the CDC to provide the H5 Subtyping Kit separately from other components of the Diagnostic Panel (Influenza A/B Typing kit, Influenza A Subtyping Kit and Influenza B Lineage Genotyping Kit). No other text in the package insert has been added or modified. Different components of the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel will be accompanied by revised labeling (package inserts) and the current submission is to clear the A/H5 subtyping kit.

The FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, and physical characteristics.

No changes were made to the intended use or physical characteristics of this test. The labelling changes did not include insertion or modification of any text, only text not relevant to the Influenza A/H5 Subtyping kit was removed.

5. A Design Control Activities Summary which includes:
a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices

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demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared device.