# K971182: Tox a/B Test

- Pathway: 510(k) (Traditional)
- Applicant: Techlab, Inc.
- Decided: Jul 22, 1997 after 113 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; 2 cite 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. The FDA summary names no predicate by number.

## Most influential descendants
- K033479: Prospect Clostridium Difficile Toxin a/B Microplate Assay (2004), 2 descendants of its own
- K030404: C. Difficile Tox a/B II (2003), 2 descendants of its own
- K050891: Tox a/B Quick Chek (2005), 1 descendant of its own
- K082499: C. Diff Quik Chek Complete (2009), 0 descendants of its own

## Indications for use
The TOX A/B TEST is an enzyme immunoassay for the detection of toxins A and B produced by toxigenic strains of Clostridium difficile. It can be used to detect 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/K971182
Methodology: https://510kreport.com/methodology