# K050891: Tox a/B Quick Chek

- Pathway: 510(k) (Traditional)
- Applicant: Techlab, Inc.
- Decided: Jul 25, 2005 after 108 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: 3 generations back to K911958 (1991). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935296: Clostridium Difficile Tox-B Test, Techlab, Inc. (1994) Summary page 1.
- K923463: Clostridium Difficile Toxin/Antitoxin Kit, Techlab, Inc. (1993) Summary page 1.
- K003306: C. Difficile Tox a/B II, Techlab, Inc. (2000) Summary page 1.
- K030404: C. Difficile Tox a/B II, Techlab, Inc. (2003) Summary page 2.
- K993914: Premier Toxins a&B, Model 616096, Meridian Diagnostics, Inc. (1999) Summary page 2.
- K033479: Prospect Clostridium Difficile Toxin a/B Microplate Assay, Remel, Inc. (2004) Summary page 2.
- K041003: Immunocard Toxins a & B, Model 712050, Meridian Bioscience, Inc. (2004) Summary page 2.
- K041951: Xpect Clostridium Difficile Toxin a/B, Remel, Inc. (2004) Summary page 1.

## Most influential descendants
- K082499: C. Diff Quik Chek Complete (2009), 0 descendants of its own

## Indications for use
The TOXA/B QUIK CHEKM test is a rapid immunoassay for detecting Clostridium difficile toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with the patient history. FOR IN VITRO DIAGNOSTIC USE.

Source page: https://510kreport.com/device/K050891
Methodology: https://510kreport.com/methodology