# K132010: Vidas C Difficile GDH

- Pathway: 510(k) (Traditional)
- Applicant: Biomerieux S.A.
- Decided: Oct 9, 2013 after 100 days
- Product code: MCB (Antigen, C. Difficile)
- Device class: 1
- Regulation: 21 CFR 866.2660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K870864 (1987). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053572: C. Diff Quik Chek, Techlab, Inc. (2006) Summary page 1.

## Indications for use
VIDASO C. difficile GDH (GDH) is an automated test based on the Enzyme linked Fluorescent Assay technique (ELFA), for use on the VIDAS family instruments. The VIDAS C. diftiile GDH (glutamate dehydrogenase) assay is a qualitative test that detects the C. diffloile antigen, glutamate dehydrogenase, as a screen for the presence of C. difficile in fecal specimens from persons suspected of having C. difficile infection (CDI). The test does not distinguish toxigenic from non-toxigenic strains of C. difficile. With the use of additional tests that detect C. difficile toxins, the test is to be used as an aid in the diagnosis of C. dufficile infection. As wvith other C. difficile tests, results should be considered in conjunction wvith the patient history.

Source page: https://510kreport.com/device/K132010
Methodology: https://510kreport.com/methodology