# K990664: Prima System - Old, Bartels Elisa - New

- Pathway: 510(k) (Special)
- Applicant: Intracel Corp.
- Decided: Mar 31, 1999 after 30 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 K913229 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913229: Bartels Clostridium Difficile Toxin a Enzym Immun, Baxter Diagnostics, Inc. (1991) Summary page 1.

## Indications for use
Bartels Clostridium difficille Toxin A Enzyme Immunoassay (EIA) is intended for the qualitative detection of Clostridium difficille Toxin A in human fecal specimens as an aid in the diagnosis of Clostridium difficille-associated disease.

Source page: https://510kreport.com/device/K990664
Methodology: https://510kreport.com/methodology