# K240867: cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems

- Pathway: 510(k) (Traditional)
- Applicant: Roche Molecular Systems, Inc.
- Decided: Feb 11, 2025 after 319 days
- Product code: QQX (Respiratory Specimen Nucleic Acid Sars-Cov-2 Test)
- 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: 4 generations back to DEN200031 (2021). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231306: cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems, Roche Molecular Systems, Inc. (2023) Summary page 5.

## Indications for use
cobas® SARS-CoV-2 Qualitative for use on the cobas®5800/6800/8800 Systems is a real-time RT-PCR test intended for the qualitative detection of nucleic acids from SARS-CoV-2 in nasopharyngeal swab specimens collected from individuals with signs and symptoms of COVID-19 and in anterior nasal swab specimens collected from any individuals with or without signs and symptoms of COVID-19. Positive results are indicative of the presence of SARS-CoV-2 RNA. Positive results do not rule out bacterial infection or co-infection with other pathogens. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Results are meant to be used in conjunction with clinical observations, patient history, recent exposures, epidemiological information, and laboratory data, in accordance with the guidelines provided by the relevant public health authorities.

Source page: https://510kreport.com/device/K240867
Methodology: https://510kreport.com/methodology