# K092953: Xpert VanA Assay

- Pathway: 510(k) (Traditional)
- Applicant: Cepheid
- Decided: Dec 17, 2009 after 84 days
- Product code: NIJ (System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species)
- 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: 2 generations back to K972359 (1997). 2 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061686: Idi-Vanr Assay, Geneohm Sciences Canada, Inc. (2006) Summary page 1.
- K972359: Remel Bile Esculin Azide Agar W/6 MCG/ML Vancomycin, Remel, L.P. (1997) Summary page 1.

## Most influential descendants
- K152614: Xpert Carba-R (2016), 6 descendants of its own
- K160901: Xpert Carba-R (2016), 3 descendants of its own
- K173263: Xpert Carba-R (2018), 1 descendant of its own
- K261867: Xpert Carba-R (2026), 0 descendants of its own
- K243405: Xpert vanA (2024), 0 descendants of its own

## Indications for use
The Cepheid Xpert® vanA Assay performed in the GeneXpert® Dx System is a qualitative in vitro diagnostic test designed for rapid detection of the vanA gene sequence associated with vancomycin resistance in bacteria obtained from rectal swab specimens from patients at risk for intestinal colonization with vancomycin-resistant bacteria. The test utilizes automated real-time polymerase chain reaction (PCR) to detect the vanA gene that is frequently associated with vancomycin-resistant enterococci (VRE). The Xpert vanA Assay is intended to aid in the recognition, prevention, and control of vancomycin-resistant organisms that colonize patients in healthcare settings. The Xpert vanA Assay is not intended to diagnose infections caused by vancomycin-resistant bacteria nor to guide or monitor treatment for vancomycin-resistant bacterial infections. Concomitant cultures are necessary to recover organisms for identification of vancomycin-resistant bacteria, antimicrobial susceptibility testing and for epidemiological typing

Source page: https://510kreport.com/device/K092953
Methodology: https://510kreport.com/methodology