# K030404: C. Difficile Tox a/B II

- Pathway: 510(k) (Traditional)
- Applicant: Techlab, Inc.
- Decided: Apr 24, 2003 after 77 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: 1 generation back to K971182 (1997). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003306: C. Difficile Tox a/B II, Techlab, Inc. (2000) Summary page 1.
- K971182: Tox a/B Test, Techlab, Inc. (1997) Summary page 1.
- K971761: Personallab Automated Microplate Analyzer, Biochem Immunosystems (U.S.), Inc. (1997) Summary page 1.

## Most influential descendants
- 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 C. DIFFICILE TOX A/B 11 test is an enzyme immunoassay for the detection of toxins A and B produced by toxigenic strains of Clostridium difficile in fecal specimens from persons suspected of having C. difficile disease and results should be considered in conjunction with the patient history. The test may be performed using either manual or automated (PersonalLab Junior, Adaltis U.S. Inc.) methods. FOR IN VITRO DIAGNOSTIC USE.

Source page: https://510kreport.com/device/K030404
Methodology: https://510kreport.com/methodology