# K030991: C. Diff Chek - 30

- Pathway: 510(k) (Traditional)
- Applicant: Techlab, Inc.
- Decided: Jul 11, 2003 after 105 days
- Product code: LLH (Reagents, Clostridium Difficile Toxin)
- 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
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K053572: C. Diff Quik Chek (2006), 3 descendants of its own
- K132010: Vidas C Difficile GDH (2013), 0 descendants of its own
- K112048: Immunocard C. Difficile GDH (2011), 0 descendants of its own
- K082499: C. Diff Quik Chek Complete (2009), 0 descendants of its own

## Indications for use
The C. DIFF CHEKTM- 30 test is an enzyme immunoassay for use as a screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens from persons suspected of having C. difficile disease. 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. difficile disease. As with other C. difficile tests, results should be considered in conjunction with the patient history. FOR IN VITRO DIAGNOSTIC USE.

Source page: https://510kreport.com/device/K030991
Methodology: https://510kreport.com/methodology