# K061686: Idi-Vanr Assay

- Pathway: 510(k) (Traditional)
- Applicant: Geneohm Sciences Canada, Inc.
- Decided: Aug 30, 2006 after 76 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.
9 later devices descend from it; 1 cites 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)
- K972359: Remel Bile Esculin Azide Agar W/6 MCG/ML Vancomycin, Remel, L.P. (1997) Summary page 1.

## Most influential descendants
- K092953: Xpert VanA Assay (2009), 8 descendants of its own
- 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

## Indications for use
The IDI-VanR® Assay is a qualitative in vitro test for the rapid detection of vancomycin-resistance (vanA and vanB) genes directly from rectal swabs. The IDI-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 rectal swabs from patients at risk for VRE colonization. The IDl-VanR® Assay can be used as an aid to identify, prevent and control vancomycin-resistant colonization in healthcare settings. Concomitant cultures are necessary to recover organisms for epidemiological typing, susceptibility testing and for further confirmatory identification. The IDI-VanR® Assay is not intended to diagnose VRE infections nor to guide or monitor treatment for VRE infections.

Source page: https://510kreport.com/device/K061686
Methodology: https://510kreport.com/methodology