# K993914: Premier Toxins a&B, Model 616096

- Pathway: 510(k) (Special)
- Applicant: Meridian Diagnostics, Inc.
- Decided: Dec 10, 1999 after 23 days
- Product code: LLH (Reagents, Clostridium Difficile Toxin)
- Device class: 1
- Regulation: 21 CFR 866.2660
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K911958 (1991). 1 ancestor in all.
3 later devices descend from it; 3 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)
- K911958: Cytoclone a & B Eia, Cambridge Biotech Corp. (1991) Summary page 1.

## Most influential descendants
- K033479: Prospect Clostridium Difficile Toxin a/B Microplate Assay (2004), 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

## Recalls of this device
- Sep 23, 2003 · Not classified · Z-0062-04: The kits were packaged with incorrect dispensing pipettes.
- Dec 26, 2002 · Not classified · Z-0464-03: Due to defective packaging, the firm cannot assure product stability through the labeled expiration date.

## Indications for use
Premier Toxins A&B is a qualitative enzyme immunoassay for the detection of Clestridium difficile toxin A and toxin B in stool from patients with antibiotic associated diarrhea. Premier Toxins A&B is intended for use as an aid in diagnosis of C. difficile associated disease.

Source page: https://510kreport.com/device/K993914
Methodology: https://510kreport.com/methodology