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Cobas Influenza A/B & RSV Nucleic Acid Test

FDA 510(k)

Class II (US FDA 510(k))

510(k) K210234

by Roche Molecular Systems, Inc.

Identifiers

510(k) Number
K210234 FDA 510(k)
FDA Product Code
OCC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.3980 FDA 510(k)
Regulation Number
866.3980 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Cobas Influenza A/B & RSV Nucleic Acid Test is a nucleic acid test for use on the Cobas Liat System. It is an automated multiplex real-time RT-PCR assay for the rapid in vitro qualitative detection and discrimination of Influenza A virus, Influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swab specimens. The test is used for the detection of these viruses.

The Cobas Influenza A/B & RSV Nucleic Acid Test is supplied for use on the Cobas Liat System. The device has received FDA 510K authorization. The test is intended for in vitro diagnostic use, and its regulation number is 866.3980. The device is classified as a Respiratory Virus Panel Nucleic Acid Assay System, with a device class of 2.

Frequently asked questions

What is the purpose of the cobas Influenza A/B & RSV Nucleic Acid Test?

This test is designed for the rapid in vitro qualitative detection and discrimination of Influenza A virus, Influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swab specimens. It helps clinicians identify these specific viruses in patients with respiratory symptoms.

How is the cobas Influenza A/B & RSV Nucleic Acid Test supplied?

The test is supplied specifically for use on the cobas Liat System, which is an automated platform that performs the nucleic acid amplification and detection process. The test components are designed to work exclusively with this system.

What is the regulatory status of this test?

The cobas Influenza A/B & RSV Nucleic Acid Test has received FDA 510K authorization with regulation number 866.3980. It is classified as a Respiratory Virus Panel Nucleic Acid Assay System with a device class of 2, indicating it is substantially equivalent to other legally marketed devices.

What type of specimens can be tested with this assay?

The test is specifically designed for use with nasopharyngeal swab specimens. It is not validated for other specimen types. The test performs automated multiplex real-time RT-PCR to detect and differentiate between Influenza A, Influenza B, and RSV RNA in these samples.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: cobas® Influenza A/B & RSV, Nucleic acid test for use on the cobas ..., PDF MS - cobas Influenza A/B & RSV, Lot 20824Y (07/24), #08160104190, Roche Diagnostics cobas™ liat Influenza A/B + RSV Multiplex Assay, Roche Diagnostics cobas Liat SARS-CoV-2, Influenza A/B and RSV RT-PCR ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Roche Molecular Systems, Inc.

Sources (1)

  • FDA 510(k) K210234 24 fields · synced Sep 26, 2026