# K102242: Osom C. Difficile Toxin a/B Test

- Pathway: 510(k) (Traditional)
- Applicant: Genzyme Corporation
- Decided: Dec 21, 2010 after 134 days
- Product code: LLH (Reagents, Clostridium Difficile Toxin)
- Device class: 1
- Regulation: 21 CFR 866.2660
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K041951 (2004). 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)
- K041951: Xpect Clostridium Difficile Toxin a/B, Remel, Inc. (2004) Summary page 2.

## Recalls of this device
- Sep 16, 2013 · Class II · Z-0015-2014: Sekisuki Diagnostics has issued a Product Correction for certain lot numbers of the OSOM C. difficile Toxin A/B Test Kit, because it has been determined that there is potential for false negative resu

## Indications for use
The OSOM C. difficile Toxin A/B Test is an immunochromatographic assay intended for the qualitative detection of Clostridium difficile toxins A and/or B in human stool samples. This test is intended as an aid in the diagnosis of C difficlle-associated disease (CDAD) in patients with symptoms of CDAD.

Source page: https://510kreport.com/device/K102242
Methodology: https://510kreport.com/methodology