# K142721: cobas MRSA/SA Test

- Pathway: 510(k) (Traditional)
- Applicant: Roche Molecular Systems, Inc.
- Decided: Dec 17, 2014 after 85 days
- Product code: NQX (System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen)
- Device class: 2
- Regulation: 21 CFR 866.1640
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K850291 (1985). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091409: Lightcycler Mrsa Advanced Test for Use with the Lightcycler 2.0 Instrument, Model 05205727, Roche Molecular Systems, Inc. (2010) Summary page 5.

## Recalls of this device
- Oct 27, 2017 · Class II · Z-1195-2018: The cobas MRSA/SA tests may have decreased performance compared to the analytical sensitivity for MSRA detection. A screening failure can lead to potential infection in the colonized patient being tes

## Indications for use
The cobas® MRSA/SA Test on the cobas® 4800 system, is a qualitative in vitro diagnostic real-time PCR assay, for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA) and S.aureus (SA) DNA from nasal swabs to aid in the prevention and control of MRSA and SA infections in healthcare settings. The cobas® MRSA/SA Test is not intended to diagnose, guide or monitor treatment for MRSA or SA infections, or provide results of susceptibility to methicillin. A negative result does not preclude MRSA/SA nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiology typing or for further susceptibility testing.

Source page: https://510kreport.com/device/K142721
Methodology: https://510kreport.com/methodology