# K041003: Immunocard Toxins a & B, Model 712050

- Pathway: 510(k) (Traditional)
- Applicant: Meridian Bioscience, Inc.
- Decided: Aug 20, 2004 after 123 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
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) Premier Toxins A & B: named in the summary without a submission number
- (no number) ImmunoCard Toxin A: named in the summary without a submission number
- (no number) C. difficile ToxA/B II: named in the summary without a submission number
- (no number) Oxoid Clearview C. difficile Toxin A: named in the summary without a submission number
- (no number) 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
- K193490: SensiTox C. difficile Toxin Test (2021), 0 descendants of its own
- K082499: C. Diff Quik Chek Complete (2009), 0 descendants of its own

## Recalls of this device
- Jun 2, 2006 · Not classified · Z-1203-06: The product may produce non-specific reactions with negative specimens and/or the negative control reagent. These non-specific interactions may result in increased invalid test rates and/or positivity

## Indications for use
ImmunoCard Toxins A & B is an in vitro diagnostic qualitative enzyme immunoassay to detect the presence of Clostridium difficile toxins A and B in human stool. The assay is used as an aid in the diagnosis of C. difficile-associated disease.

Source page: https://510kreport.com/device/K041003
Methodology: https://510kreport.com/methodology