# K080837: Xpert Mrsa/SA Ssti Assay

- Pathway: 510(k) (Traditional)
- Applicant: Cepheid
- Decided: Sep 24, 2008 after 183 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: 3 generations back to K850291 (1985). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070462: Xpert Mrsa, Cepheid (2007) Summary page 1.
- K071026: BD Geneohm Staphsr Assay, Bd Diagnostics (Geneohm Sciences Canada, Inc) (2007) Summary page 2.
- K851949: Staphaurex ZL30, Wellcome Diagnostics (1985) Summary page 3.
- K863821: Mueller Hinton Agar W/4%Nacl and Oxacillin, Gibco Laboratories Life Technologies, Inc. (1986) Summary page 3.
- K042812: Bblchromagar Mrsa, Becton, Dickinson & CO (2004) Summary page 3.
- K020322: BD Phoenix Automated Microbiology System, Becton, Dickinson & CO (2002) Summary page 3.
- K023301: BD Phoenix Automated Microbiology System, Becton, Dickinson & CO (2002) Summary page 3.

## Most influential descendants
- K243625: Xpert MRSA/SA SSTI (2024), 0 descendants of its own

## Indications for use
The Cepheid Xpert MIRSA/SA Skin and Soft Tissues Infection Assay (Xpert MRSA/SA SSTI Assay) performed in the GeneXpert® Dx System is a qualitative in vitro diagnostic test intended for the detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) from skin and soft tissue infection swabs. The test utilizes automated real-time polymerase chain reaction (PCR) to detect MRSA/SA DNA. The Xpert MRSA/SA SSTI Assay 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 MRSA/SA from skin and soft tissue infections. The Xpert MRSA/SA SSTI Assay is not intended to monitor treatment for MRSA/SA infections. Concomitant cultures for SA and MRSA are necessary to recover organisms for susceptibility testing or epidemiological typing. In a mixed culture containing MRSA/SA and other organisms (e.g. Gram negative bacilli, yeast), results can be false negative or variable depending on the concentration of MRSA/SA present, particularly if the concentration of MRSA/SA is close to the LoD of the assay.

Source page: https://510kreport.com/device/K080837
Methodology: https://510kreport.com/methodology