# K112048: Immunocard C. Difficile GDH

- Pathway: 510(k) (Traditional)
- Applicant: Meridian Bioscience, Inc.
- Decided: Dec 16, 2011 after 151 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
ImmunoCard C. clificile GDH is a rapid qualitative enzyme immunoassay screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens from persons suspected of having C. clifficile infection (CDI). This test does not distinguish between toxigenic and non-toxigenic strains of C. difficile. Samples from patients that produce positive results with this test must be further tested with an assay designed to detect toxigenic C. clifficile strains and assist with the diagnosis of CDL.

Source page: https://510kreport.com/device/K112048
Methodology: https://510kreport.com/methodology