# K102416: BD Geneohm Vanr Assay

- Pathway: 510(k) (Traditional)
- Applicant: Bd Diagnostics Science
- Decided: Oct 20, 2011 after 422 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: 1 generation back to K972359 (1997). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972359: Remel Bile Esculin Azide Agar W/6 MCG/ML Vancomycin, Remel, L.P. (1997) Summary page 1.

## Most influential descendants
- K123753: Imdx Vanr for Abbott M2000 (2013), 0 descendants of its own

## Indications for use
The BID GeneOhm Tm VanR Assay is a qualitative in vitro test for the rapid detection of vancomycin-resistance (vanA and vanB) genes directly from perianal or rectal swabs. The BD GeneOhmTm VanR Assay detects the presence of the vanA and vanB genes that can be associated with vancomycin-resistant enterococci (VRE). The assay is performed on an automated real-time PCR instrument with perianal or rectal swabs from individuals at risk for VRE colonization. The BID GeneOh MTM VanR Assay can be used as an aid to identify, prevent and control vancomycin-resistant colonization in healthcare settings. The BD GeneOhmTM VanR Assay is not intended to diagnose VRE infections nor to guide or monitor treatment for VRE infections. Concomitant cultures are necessary to recover organisms for epidemiological typing, susceptibility testing and for further confirmatory identification.

Source page: https://510kreport.com/device/K102416
Methodology: https://510kreport.com/methodology