# K972359: Remel Bile Esculin Azide Agar W/6 MCG/ML Vancomycin

- Pathway: 510(k) (Traditional)
- Applicant: Remel, L.P.
- Decided: Aug 28, 1997 after 64 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
No predicates in its family tree.
19 later devices descend from it; 6 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K061686: Idi-Vanr Assay (2006), 9 descendants of its own
- 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
- K122187: Vreselect Culture Medium (2012), 3 descendants of its own

## Recalls of this device
- Apr 22, 2021 · Class II · Z-1561-2021: The media allows growth of E. faecalis ATCC 29212 with blackening of the media.

## Indications for use
REMEL's Bile Esculin Azide Agar w/ 6 pg/ml Vancomycin is a plated medium recommended for use in qualitative procedures as a selective and differential medium for the primary isolation of vancomycin resistant enterococci from surveillance cultures. This product is not intended for use as method of antimicrobial susceptibility testing. Confirmation of vancomycin resistance by an approved method is recommended as some organisms on initial isolation may overcome the inhibitory effects of the medium.

Source page: https://510kreport.com/device/K972359
Methodology: https://510kreport.com/methodology