# K153544: cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System

- Pathway: 510(k) (Dual Track)
- Applicant: Iquum, Inc.
- Decided: Jul 25, 2016 after 227 days
- Product code: OCC (Respiratory Virus Panel Nucleic Acid Assay System)
- Device class: 2
- Regulation: 21 CFR 866.3980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to DEN070013 (2008). 14 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111387: Liat (TM) Influenza a / B Assay, Liat (TM) Analyzer, Iquum, Inc. (2011) Summary page 9.
- K073029: Proflu+ Assay, Prodesse, Inc. (2008) Summary page 9.
- K081030: Modification to Proflu+ Assay, Prodesse, Inc. (2008) Summary page 9.
- K092500: Modification to Proflu+ Assay, Prodesse, Inc. (2009) Summary page 9.
- K110968: Proflu+ Assay, Gen-Probe Prodesse, Inc. (2011) Summary page 9.
- K132129: Prodesse Proflu+ Assay, Gen-Probe Prodesse, Inc. (2013) Summary page 9.

## Most influential descendants
- K200065: cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System, cobas Strep A Nucleic acid test for use on the cobas Liat System (2020), 3 descendants of its own
- K210234: cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System (2021), 1 descendant of its own
- K260047: cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190) (2026), 0 descendants of its own
- K213822: cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System (2022), 0 descendants of its own

## Indications for use
The cobas® Influenza A/B & RSV Nucleic Acid Test for Use on the cobas® Liat System (cobas® Liat Influenza A/B & RSV) 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 from patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors. The test is intended for use as an aid in the diagnosis and differentiation of influenza A, influenza B, and RSV in humans and is not intended to detect influenza C. Negative results do not preclude influenza virus or RSV 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. Performance characteristics for influenza A were established during the 2013-2014 and the 2014-2015 influenza seasons when influenza A/H3 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary. 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 in these cases unless a BSL 3+ facility is available to receive and culture specimens. The cobas® Influenza A/B & RSV Quality Control Kit contains External Controls for use with the cobas® Liat Influenza A/B & RSV assay. External Controls are run during the Add cobas® Liat Influenza A/B & RSV Tube Lot procedure. Additional External Controls should be tested in accordance with local, state, federal and/or accrediting organization requirements as applicable.

Source page: https://510kreport.com/device/K153544
Methodology: https://510kreport.com/methodology