# K103684: Vreselect Culture Medium

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Oct 21, 2011 after 308 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation 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)
- K092819: Remel Spectra Vre, Thermo Fisher Scientific (2010) Summary page 1.
- K972359: Remel Bile Esculin Azide Agar W/6 MCG/ML Vancomycin, Remel, L.P. (1997) Summary page 1.

## Indications for use
VRESelect TM is a selective and differential chromogenic medium, containing 8 jig/mL of vancomycin, for the qualitative detection of gastrointestinal colonization of vancomycin-resistant Enterococcusfaecium (VREfmn) and vancomycin-resistant Enterococcusfaecalis(VREfs) and to aid in the prevention and control of vancomycin-resistant Enterococcus (VRE) in healtheare settings. The test is performed on rectal swabs from patients to be screened for VRE colonization. VRESelect TM is not intended to diagnose VRE infection nor to guide or monitor treatment of infection. Results can be interpreted after 24 to 28 hours incubation. Subculture to non-selective media (e.g., trypticase soy agar with 5% sheep blood) is need for susceptibility testing and epidemiological typing.

Source page: https://510kreport.com/device/K103684
Methodology: https://510kreport.com/methodology