# K122187: Vreselect Culture Medium

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Nov 6, 2012 after 105 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.
3 later devices descend from it; 2 cite it directly.
0 of 6 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.

## Most influential descendants
- K160512: HardyCHROM ESBL (2016), 1 descendant of its own
- K190553: HardyCHROM CRE (2019), 0 descendants of its own
- K162620: Remel Spectra ESBL (2017), 0 descendants of its own

## Indications for use
VRESelect TM is a selective and differential chromogenic medium, containing 8 pg/mL of vancomycin, for the qualitative detection of gastrointestinal colonization of vancomycin-resistant Enterococcus faecium (VREfm) and vancomycin-resistant Enterococcus faecalis (VREfs) and to aid in the prevention and control of vancomycin-resistant Enterococcus (VRE) in healthcare settings. The test is performed on rectal swabs or fecal specimens from patients to be screened for VRE colonization. VRESelectTh 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 needed for susceptibility testing and epidemniological typing.

Source page: https://510kreport.com/device/K122187
Methodology: https://510kreport.com/methodology