# K091025: Chromid Vre Agar, Model: Ref 43 851

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Mar 2, 2010 after 326 days
- Product code: JSO (Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar)
- Device class: 2
- Regulation: 21 CFR 866.1700
- Recalls of this device: 1 (0 Class I)
- 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
- K181092: CHROMID CARBA agar (CARB) (2018), 0 descendants of its own

## Recalls of this device
- Nov 9, 2022 · Class II · Z-0803-2023: As the temperature and time out of range was exceeded, product performances cannot be guaranteed

## Indications for use
chromllorM VRE agar is a selective and differential chromogenic medium containing 8 pg/mL of vancomycin, for the qualitative detection of Enterococcus faecium and B. faecalis showing acquired vancomycin resistance (VRE) in stool specimens. chromlD TM VRE agar can be used as an aid to identify, prevent and control VRE colonization in healthcare settings. chromlD TM VRE agar is not intended to diagnose VRE infection nor to guide or monitor treatment for infections. Subculture to non-selective media (e.g. trypticase soy agar with 5% sheep blood) is needed for further identification, susceptibility testing and epidemiological typing.

Source page: https://510kreport.com/device/K091025
Methodology: https://510kreport.com/methodology