# K033479: Prospect Clostridium Difficile Toxin a/B Microplate Assay

- Pathway: 510(k) (Traditional)
- Applicant: Remel, Inc.
- Decided: Feb 26, 2004 after 115 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: 2 generations back to K911958 (1991). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993914: Premier Toxins a&B, Model 616096, Meridian Diagnostics, Inc. (1999) Summary page 1.
- K003306: C. Difficile Tox a/B II, Techlab, Inc. (2000) Summary page 1.
- K971182: Tox a/B Test, Techlab, 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
Remel's ProSpecT® Clostridium difficile Toxin A/B Microplate Assay is a qualitative enzyme immunoassay (EIA) for the detection of C. difficile Toxin A and B in human fecal specimens from patients suspected of having Clostridium difficile disease. The test is intended for use as an aid in diagnosis of Clostridium difficile-associated disease (CDAD).

Source page: https://510kreport.com/device/K033479
Methodology: https://510kreport.com/methodology