# K243400: cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test

- Pathway: 510(k) (Dual Track)
- Applicant: Roche Molecular Systems, Inc.
- Decided: Apr 25, 2025 after 176 days
- Product code: QOF (Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents)
- Device class: 2
- Regulation: 21 CFR 866.3981
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN200031 (2021). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241240: Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, Hologic, Inc. (2024) Summary page 5.

## Indications for use
The cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test is an automated rapid multiplex real-time reverse transcription polymerase chain reaction (RT-PCR) test intended for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A virus and influenza B virus nucleic acids in anterior nasal (nasal) and nasopharyngeal swab specimens from individuals exhibiting signs and symptoms of respiratory tract infection. Clinical signs and symptoms of respiratory tract infection due to SARS-CoV-2 and influenza can be similar. This test is intended to aid in the differential diagnosis of SARS-CoV-2, influenza A and influenza B infections in humans and is not intended to detect influenza C virus infections. Nucleic acids from the viral organisms identified by this test are generally detectable in nasopharyngeal and nasal swab specimens during the acute phase of infection. The detection and identification of specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory tract infection are indicative of the presence of the identified virus, and aid in diagnosis if used in conjunction with other clinical and epidemiological information and laboratory findings. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Positive results do not rule out coinfection with other organisms. The organism(s) detected by the cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2, influenza A virus or influenza B virus infections.

Source page: https://510kreport.com/device/K243400
Methodology: https://510kreport.com/methodology