# K243070: Xpert® SA Nasal Complete

- Pathway: 510(k) (Special)
- Applicant: Cepheid®
- Decided: Oct 25, 2024 after 28 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: 1 generation back to K100822 (2010). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100822: Xpert Mrsa/SA Nasal Assay, Cepheid (2010) Summary page 6.

## Recalls of this device
- Aug 6, 2025 · Class II · Z-0414-2026: As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.

## Indications for use
The Xpert® SA Nasal Complete test performed on the GeneXpert® Instrument Systems is a qualitative in vitro diagnostic test designed for detection of Staphylococcus aureus (SA) and 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/SA DNA. The Xpert® SA Nasal Complete test is intended to aid in the prevention and control of MRSA/SA infections in healthcare settings. The Xpert® SA Nasal Complete test is not intended to diagnose, guide or monitor treatment for MRSA/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 epidemiological typing or for further susceptibility testing.

Source page: https://510kreport.com/device/K243070
Methodology: https://510kreport.com/methodology