# K980185: Colorpac Toxin a

- Pathway: 510(k) (Traditional)
- Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decided: Jul 17, 1998 after 178 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Cytotoxin B: named in the summary without a submission number

## Indications for use
The ColorPAC™ Toxin A test is indicated for the qualitative detection of Clostridium difficile toxin A (enterotoxin) in stool specimens from patients suspected of having C. difficile associated disease. The test can also be used for the confirmation of suspect colonies of toxigenic C. difficile from agar plates or BHI broth. The assay is intended for use as an aid in the diagnosis of C. difficile associated disease. The test is not indicated for asymptomatic adults or children. This device is not intended for use in a point of care setting.

Source page: https://510kreport.com/device/K980185
Methodology: https://510kreport.com/methodology