# K092819: Remel Spectra Vre

- Pathway: 510(k) (Traditional)
- Applicant: Thermo Fisher Scientific
- Decided: Jul 15, 2010 after 304 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
No predicates in its family tree.
5 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)
- None. The FDA summary names its predicate without a number.
- (no number) Remel Bile Esculin Azide Agar with 6 pg/ml Vancomycin: named in the summary without a submission number

## Most influential descendants
- K122187: Vreselect Culture Medium (2012), 3 descendants of its own
- 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
- K103684: Vreselect Culture Medium (2011), 0 descendants of its own

## Indications for use
Remel Spectra TM VRE is a selective and differential chromogenic medium, containing 6 pg/mi of vancomycin, intended for use in the qualitative detection of gastrointestinal colonization with vancomycin-resistant Enterococcus faecium and Enterococcus faecalis (VIRE) to aid in the prevention and control of VRE in healthcare settings. The test is performed with rectal swab and fecal specimens from patients to screen for VRE colonization. Spectra TM VRE is not intended to diagnose VRE infection or to guide* or monitor treatment for infections. Subculture to non-selective media (e.g. Tryptic Soy Agar with 5% sheep blood) is needed for further identification, susceptibility testing, and epidemiological typing.

Source page: https://510kreport.com/device/K092819
Methodology: https://510kreport.com/methodology