# K123998: Quidel Molecular Direct C. Difficile Assay

- Pathway: 510(k) (Traditional)
- Applicant: Quidel Corp.
- Decided: Mar 8, 2013 after 72 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.
2 later devices descend from it; 2 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)
- 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
- K171441: ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit (2017), 0 descendants of its own
- K133936: Artus C. Difficile QS-RGQ MDX Kit (2014), 0 descendants of its own

## Indications for use
The Quidel Molecular Direct C. difficile Assay is a qualitative, multiplexed in vitro diagnostic test for the direct detection of toxin A gene (tcdA4) or toxin B gene (tcdB) sequences of toxigenic strains of Clostridium dificile from unformed (liquid or soft) stool specimens collected from patients suspected of having Clostridiumdifficile-Associated Disease (CDAD). The Quidel Molecular Direct C. difficile Assay is a real-time PCR test and utilizes proprietary sample preparation with fluorescently labeled primers and probes. The assay can be performed using either the Life Technologies QuantStudiog Dx; the Applied Biosystems 7500 Fast Dx, or the Cepheid SmartCycler 11, to detect the toxin gene sequences associated with toxin-producing C. dffficile strains. The assay is intended to be performed directly on CDAD-suspected stool specimens, and is indicated for use as an aid in the diagnosis of CDAD.

Source page: https://510kreport.com/device/K123998
Methodology: https://510kreport.com/methodology