# K070462: Xpert Mrsa

- Pathway: 510(k) (Traditional)
- Applicant: Cepheid
- Decided: Apr 17, 2007 after 60 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: 2 generations back to K850291 (1985). 3 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033415: Idi-Mrsa, Infectio Diagnostic (I.D.I.), Inc. (2004) Summary page 1.

## Most influential descendants
- K093346: BD Geneohm Mrsa Acp Assay (2009), 7 descendants of its own
- K120138: BD Max Mrsa Assay, BD Max Instrument (2012), 4 descendants of its own
- K133605: BD Max Mrsa XT, BD Max Instrument (2013), 2 descendants of its own
- K112937: Mrsa/SA Elite MGB (2012), 1 descendant of its own
- K080837: Xpert Mrsa/SA Ssti Assay (2008), 1 descendant of its own

## Recalls of this device
- Jul 18, 2016 · Class II · Z-2548-2016: Internal investigation found the certain lots of MRSA kits have the potential for performance issues at lower positive sample concentrations.

## Indications for use
The Cepheid Xpert MRSA Assay performed on the GeneXpert® Dx System (Xpert MRSA) is a qualitative in vitro diagnostic test designed for rapid detection of methicillin-resistant Staphylococcus aureus (MRSA) from nasal swabs in patients at risk for nasal colonization. The test utilizes automated real-time polymerase chain reaction (PCR) to detect MRSA DNA. The Xpert MRSA Assay is intended to aid in the prevention and control of MRSA infections in healthcare settings. The Xpert MRSA Assay is not intended to diagnose MRSA nor to guide or monitor treatment for MRSA infections. Concomitant cultures are necessary only to recover organisms for epidemiological typing or for further susceptibility testing.

Source page: https://510kreport.com/device/K070462
Methodology: https://510kreport.com/methodology