cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System

K213822 · Roche Molecular Systems, Inc. · OCC · Jul 6, 2022 · Microbiology

Device Facts

• Record ID: K213822
• Device Name: cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System
• Applicant: Roche Molecular Systems, Inc.
• Product Code: OCC · Microbiology
• Decision Date: Jul 6, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3980
• Device Class: Class 2

Indications for Use

The cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System is a multiplex real-time RT-PCR assay for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swab specimens collected from individuals with signs and symptoms of respiratory tract infection. The test is intended for use as an aid in the diagnosis of influenza A, influenza B, and RSV infections in humans in conjunction with clinical and epidemiological risk factors. The test is intended for use on the cobas Liat System.

Device Story

Multiplex real-time RT-PCR assay; detects/differentiates influenza A, influenza B, and RSV RNA in nasopharyngeal swabs. Used on cobas Liat System; automated workflow. Modification: replacement of cobas Dilution UTM with Roche Negative Buffer (NEG BUF) for negative/positive control diluents. No impact on assay workflow or clinical specimen testing. Intended for clinical laboratory use to aid diagnosis of respiratory infections.

Clinical Evidence

No clinical data; bench testing only. Verification activities performed based on risk analysis to confirm functional equivalence of the new buffer material.

Technological Characteristics

Multiplex real-time RT-PCR assay. Instrumentation: cobas Liat System. Modification: substitution of cobas Dilution UTM with Roche Negative Buffer (NEG BUF) for control diluents. Fundamental technology unchanged.

Indications for Use

Indicated for patients with signs and symptoms of respiratory infection to aid in the differential diagnosis of Influenza A, Influenza B, and RSV. Not intended to detect Influenza C.

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

• cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System (K213822 - original clearance)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K213822

B Applicant

Roche Molecular Systems, Inc.

C Proprietary and Established Names

cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| OCC | Class II | 21 CFR 866.3980 - Respiratory Viral Panel Multiplex Nucleic Acid Assay | MI - Microbiology |
| OOI | Class II | 21 CFR 862.2570 - Instrumentation for clinical multiplex test systems | CH - Clinical Chemistry |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device.
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use and package labeling.

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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3. A description of the device **MODIFICATION(S)**, including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the **FUNDAMENTAL SCIENTIFIC TECHNOLOGY** of the modified device has not changed. This change was for negative control and positive control diluent for cobas Influenza A/B & RSV (FRTA) from cobas Dilution UTM to the functionally equivalent buffer material, Roche Negative Buffer (NEG BUF). The change to the negative control buffer and positive control diluent has no impact on the assay workflow. The change does not affect clinical specimen testing.

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

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 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.

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