# K123753: Imdx Vanr for Abbott M2000

- Pathway: 510(k) (Traditional)
- Applicant: Intelligent Medical Devices, Inc.
- Decided: Jul 17, 2013 after 223 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.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102416: BD Geneohm Vanr Assay, Bd Diagnostics Science (2011) Summary page 2.

## Indications for use
The IMDx VanR for Abbott m2000 assay is an in vitro diagnostic assay that uses polymerase chain reaction (PCR) amplification for the qualitative detection of nucleic acids encoding the vancomycin resistance genes vanA4 and/or vanB. The assay is performed directly on human peni-rectal swabs, rectal swabs, or stool specimens from patients at risk for Vancomycin-Resistant Enterococcus (VRE) colonization. The IMDx VanR for Abbott m2000 assay detects the presence of vanA4 and vanE genes that can be associated with vancomycin-resistant enterococci. The IMDx VanR for Abbott m2000 assay can be used as an aid to identify, prevent and control vancomycin-resistant colonization in healthcare settings. The IMDx VanR for Abbott m2000 assay is not intended to diagnose VRE infection nor to guide or monitor treatment of infection. Culture methods are necessary to recover organisms for epidemiology typing and confirmation testing.

Source page: https://510kreport.com/device/K123753
Methodology: https://510kreport.com/methodology