# K935296: Clostridium Difficile Tox-B Test

- Pathway: 510(k) (Traditional)
- Applicant: Techlab, Inc.
- Decided: Apr 26, 1994 after 174 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.
21 later devices descend from it; 3 cite it directly.
0 of 22 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
- K081920: BD Geneohm Cdiff Assay (2008), 18 descendants of its own
- K130470: BD Max Cdiff Assay, BD Max Instrument (2013), 10 descendants of its own
- K142422: cobas Cdiff Test (2015), 5 descendants of its own
- K091109: Xpert C. Difficile (2009), 5 descendants of its own
- K171770: cobas Cdiff Nucleic acid test for use on the cobas Liat System (2017), 4 descendants of its own

Source page: https://510kreport.com/device/K935296
Methodology: https://510kreport.com/methodology