# K123355: Amplivue C. Difficile Assay

- Pathway: 510(k) (Traditional)
- Applicant: Quidel Corporation
- Decided: Dec 13, 2012 after 43 days
- Product code: OZN (C. Difficile Toxin Gene Amplification Assay)
- Device class: 2
- Regulation: 21 CFR 866.3130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN120013: C. Difficile Nucleic Acid Amplification Test Assay. Our reading of the summary gave K113358, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN120013, C. Difficile Nucleic Acid Amplification Test Assay (), granted —; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Most influential descendants
- K132235: Imdx C.Difficile for Abbott M2000 (2013), 0 descendants of its own

## Indications for use
The AmpliVueTM C. difficile assay is an in vitro diagnostic test for the direct, qualitative detection of the Clostridium difficile Toxin A gene (tcdA) in unformed stool specimens of patients suspected of having Clostridium difficile-associated disease (CDAD). The AmpliVue T M C. difficile assay is intended for use as an aid in diagnosis of CDAD. The assay utilizes helicase-dependent amplification (HDA) for the amplification of a highly conserved fragment of the Toxin A gene sequence and a self-contained disposable amplification detection device that allows for manual evaluation of assay results.

Source page: https://510kreport.com/device/K123355
Methodology: https://510kreport.com/methodology