# K101879: Xpert Mrsa/SA BC (Blood Culture) Assay Model Gxmrsa/SA-BC-10

- Pathway: 510(k) (Special)
- Applicant: Cepheid
- Decided: Jul 28, 2010 after 22 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: 4 generations back to K020322 (2002). 10 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082140: Xpert Mrsa/SA Blood Culture Assay, Cepheid (2008) Summary page 1.

## Most influential descendants
- K130894: Xpert Mrsa/SA Blood Culture Assay; Genexpert DX Systems (GX-I, GX-II, GX-IV, GX-Xvi); Genexpert Infinity-48 System; Gene (2013), 1 descendant of its own
- K190771: Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System (2019), 0 descendants of its own

## Recalls of this device
- Nov 17, 2011 · Not classified · Z-0453-2012: Cepheid has received reports from some of its customers regarding higher than desired (>5%) rates of invalid results when using lot numbers 2803 and 3001 of the Xpert MRSA/SA BC (blood culture) produc

## Indications for use
The Cepheid Xpert™ MRSA/SA Blood Culture Assay performed on 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) DNA directly from patient positive blood cultures. The assay utilizes automated real-time polymerase chain reaction (PCR) for the amplification of MRSA/SA specific DNA targets and fluorogenic target-specific hybridization probes for the real-time detection of the amplified DNA. The assay is performed directly on positive blood culture specimens using BD BACTEC™ Plus Aerobic/F blood culture bottles that are determined as Gram Positive Cocci in Clusters (GPCC) or as Gram Positive Cocci in singles (GPC) by Gram stain. The Xpert MRSA/SA Blood Culture Assay is indicated for use in conjunction with other laboratory tests, such as culture, and clinical data available to the clinician as an aid in the detection of MRSA/SA from patient positive blood cultures. Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing or for epidemiological typing. The Cepheid Xpert™ MRSA/SA Blood Culture Assay is not intended to monitor treatment for MRSA/SA infections. When an MRSA negative/SA positive result is obtained, the result should be interpreted as "MRSA indeterminate/SA Positive, antimicrobial susceptibility testing pending". Further testing should be performed using an FDA-cleared, phenotypic antimicrobial susceptibility testing method on isolated colonies recovered from the blood culture bottle. MRSA positive/SA Positive results should be reported as such.

Source page: https://510kreport.com/device/K101879
Methodology: https://510kreport.com/methodology