# K082140: Xpert Mrsa/SA Blood Culture Assay

- Pathway: 510(k) (Traditional)
- Applicant: Cepheid
- Decided: Sep 29, 2008 after 61 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K020322 (2002). 9 ancestors in all.
3 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)
- K071026: BD Geneohm Staphsr Assay, Bd Diagnostics (Geneohm Sciences Canada, Inc) (2007) Summary page 3.
- K851949: Staphaurex ZL30, Wellcome Diagnostics (1985) Summary page 1.
- K863821: Mueller Hinton Agar W/4%Nacl and Oxacillin, Gibco Laboratories Life Technologies, Inc. (1986) Summary page 1.
- K042812: Bblchromagar Mrsa, Becton, Dickinson & CO (2004) Summary page 1.
- K020322: BD Phoenix Automated Microbiology System, Becton, Dickinson & CO (2002) Summary page 1.
- K023301: BD Phoenix Automated Microbiology System, Becton, Dickinson & CO (2002) Summary page 1.

## Most influential descendants
- K101879: Xpert Mrsa/SA BC (Blood Culture) Assay Model Gxmrsa/SA-BC-10 (2010), 2 descendants of its own
- 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
- Apr 5, 2010 · Not classified · Z-1898-2010: The firm is receiving reports of inaccurate results, which may result in delay of care for seriously ill patients.

## Indications for use
The Cepheid Xpert TM MRSA/SA Blood Culture Assay performed on the GeneXpert® Dx SystemTM 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 BACTECTM 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 Cepheid Xpert TM MRSA/SA Blood Culture Assay is not intended to monitor treatment for MRSA/SA infections. Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing or for epidemiological typing.

Source page: https://510kreport.com/device/K082140
Methodology: https://510kreport.com/methodology