# K243625: Xpert MRSA/SA SSTI

- Pathway: 510(k) (Special)
- Applicant: Cepheid®
- Decided: Dec 18, 2024 after 23 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K850291 (1985). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080837: Xpert Mrsa/SA Ssti Assay, Cepheid (2008) Summary page 6.

## Indications for use
The Xpert® MR.SA/SA Skin and Soft Tissue Infection test (Xpert MR.SA/SA SSTI test) performed on the GeneXpert® Instrument Systems is a qualitative in vitro diagnostic test intended for the detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MR.SA) from skin and soft tissue infection swabs. The test utilizes automated real-time polymerase chain reaction (PCR) to detect MR.SA/SA DNA. The Xpert MR.SA/SA SSTI test is indicated for use in conjunction with other laboratory tests, such as microbiology culture, and clinical data available to the clinician as an aid in the detection of MR.SA/SA from skin and soft tissue infections. The Xpert MR.SA/SA SSTI test is not intended to monitor treatment for MR.SA/SA infections. Concomitant cultures for SA and MR.SA are necessary to recover organisms for susceptibility testing or epidemiological typing. In a mixed culture containing MR.SA/SA and other organisms (e.g., Gram-negative bacilli, yeast), results can be false negative or variable depending on the concentration of MR.SA/SA present, particularly if the concentration of MR.SA/SA is close to the limit of detection (LoD) of the test.

Source page: https://510kreport.com/device/K243625
Methodology: https://510kreport.com/methodology