# K003306: C. Difficile Tox a/B II

- Pathway: 510(k) (Special)
- Applicant: Techlab, Inc.
- Decided: Nov 22, 2000 after 33 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; 4 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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

Source page: https://510kreport.com/device/K003306
Methodology: https://510kreport.com/methodology