# K053572: C. Diff Quik Chek

- Pathway: 510(k) (Traditional)
- Applicant: Techlab, Inc.
- Decided: Apr 26, 2006 after 125 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: 1 generation back to K870864 (1987). 5 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030992: C. Diff Chek - 60, Techlab, Inc. (2003) Summary page 1.
- K030991: C. Diff Chek - 30, Techlab, Inc. (2003) Summary page 1.
- K870864: Culturette Brand CDT Clostridium Difficile Test, Marion Laboratories, Inc. (1987) Summary page 1.
- K974881: Triage C. Difficile, Triage C. Difficile Panel, Triage C. Difficile Toxin a, Biosite Incorporated (1998) Summary page 1.
- K924979: Immunocard (TM) C. Difficile, Meridian Diagnostics, Inc. (1993) Summary page 1.
- (no number) C. difficile Presumptive bacterial culture: named in the summary without a submission number

## Most influential descendants
- 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 QUIK CHEK™ test is a rapid membrane 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 nontoxigenic 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.

Source page: https://510kreport.com/device/K053572
Methodology: https://510kreport.com/methodology