# K082499: C. Diff Quik Chek Complete

- Pathway: 510(k) (Traditional)
- Applicant: Techlab, Inc.
- Decided: Mar 26, 2009 after 209 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
Longest line of descent: 4 generations back to K911958 (1991). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 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 3.
- K030992: C. Diff Chek - 60, Techlab, Inc. (2003) Summary page 3.
- K870864: Culturette Brand CDT Clostridium Difficile Test, Marion Laboratories, Inc. (1987) Summary page 3.
- K924979: Immunocard (TM) C. Difficile, Meridian Diagnostics, Inc. (1993) Summary page 3.
- K935296: Clostridium Difficile Tox-B Test, Techlab, Inc. (1994) Summary page 4.
- K050891: Tox a/B Quick Chek, Techlab, Inc. (2005) Summary page 4.
- K003306: C. Difficile Tox a/B II, Techlab, Inc. (2000) Summary page 4.
- K030404: C. Difficile Tox a/B II, Techlab, Inc. (2003) Summary page 4.
- K993914: Premier Toxins a&B, Model 616096, Meridian Diagnostics, Inc. (1999) Summary page 4.
- K033479: Prospect Clostridium Difficile Toxin a/B Microplate Assay, Remel, Inc. (2004) Summary page 4.
- K041003: Immunocard Toxins a & B, Model 712050, Meridian Bioscience, Inc. (2004) Summary page 4.
- K041951: Xpect Clostridium Difficile Toxin a/B, Remel, Inc. (2004) Summary page 4.
- K974881: Triage C. Difficile, Triage C. Difficile Panel, Triage C. Difficile Toxin a, Biosite Incorporated (1998) Summary page 3.
- (no number) C. difficile Culture Media such as cycloserine-cefoxitin fructose agar (CCFA): named in the summary without a submission number
- (no number) C. difficile Toxin/Antitoxin along with human foreskin monolayer tissue cultured cells (Diagnostic Hybrids): named in the summary without a submission number

## Indications for use
The C. DIFF QUIK CHEK COMPLETE rM test is a rapid, membrane enzyme immunoassay for the simultaneous detection of Clostridium difficile glutamate dehydrogenase antigen and toxins A and B in a single reaction well. The test detects C. difficile antigen, glutamate dehydrogenase, as a screen for the presence of C. difficile and confirms the presence of toxigenic C. difficile by detecting toxins A and B in fecal specimens from persons suspected of havihg C. difficile disease. 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/K082499
Methodology: https://510kreport.com/methodology