# K132235: Imdx C.Difficile for Abbott M2000

- Pathway: 510(k) (Traditional)
- Applicant: Intelligent Medical Devices, Inc.
- Decided: Oct 11, 2013 after 85 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
Longest line of descent: 1 generation back to K123355 (2012). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123355: Amplivue C. Difficile Assay, Quidel Corporation (2012) Summary page 2.

## Indications for use
The IMDx C. difficile for Abbott m20C0 assay is an in vitro diagnostic assay that uses real-time polymerase chain reaction.(PCR) amplification for the qualitative detection of nucleic acids encoding the toxin A gene (tcdA) and toxin B gene (tcdB ) sequences of toxigenic strains of Clostridium diffidile in human liquid or soft stool specimens collected from patients suspected of having symptoms of Clostridium difficile infection. The assay is intended to be performed on the Abbott m2000 System (which comprises the Abbott m2000sp and m:2000rt instruments) and is indicated for use as an aid in the diagnosis of Clostridium di~flcile infection. The test is intended to be used directly on liquid or soft stool specimens (unpreserved stool, or stool preserved in Gary Blair transport medium). Negative results do not preclude toxigenic C difficile infection and should not be used as the sole basis for treatment or other patient management decisions. The IMDx C. difficile for Abbott m2600 assay is intended for professional use. The device is not intended for point-of-care use.

Source page: https://510kreport.com/device/K132235
Methodology: https://510kreport.com/methodology