# K020576: Velogene Genomic Identificationassay for Vre

- Pathway: 510(k) (Traditional)
- Applicant: Id Biomedical Corp.
- Decided: May 1, 2002 after 69 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 K941444 (1994). 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)
- K941444: Bhi Agar with Vancomycin, Remel Co. (1994) Summary page 3.
- K964560: Bhi W/Vancomycin Agar, Hardy Diagnostics (1997) Summary page 3.

## Indications for use
For the visual or spectrophotometric detection of the vand and vanB genes in determining vancomycin resistance in enterococei isolated from culture.

Source page: https://510kreport.com/device/K020576
Methodology: https://510kreport.com/methodology