# K041951: Xpect Clostridium Difficile Toxin a/B

- Pathway: 510(k) (Traditional)
- Applicant: Remel, Inc.
- Decided: Nov 15, 2004 after 118 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
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) BD ColorPAC Toxin A: named in the summary without a submission number

## Most influential descendants
- K050891: Tox a/B Quick Chek (2005), 1 descendant of its own
- K102242: Osom C. Difficile Toxin a/B Test (2010), 0 descendants of its own
- K082499: C. Diff Quik Chek Complete (2009), 0 descendants of its own

## Indications for use
REMEL's Xpect TM Clostridium difficile Toxin A/B is a rapid in vitro immunochromatographic test for the direct, qualitative detection of Clostridium difficile Toxin A and/or B in human fecal specimens from patients suspected of having Clostridium difficile-associated disease (ODAD). The test is intended for use as an aid in diagnosis of CDAD. The test can also be used for confirmation of toxigenic Clostridium difficile from Brain Heart Infusion (BHI) broth culture.

Source page: https://510kreport.com/device/K041951
Methodology: https://510kreport.com/methodology