# K132726: Iceplex C. Difficile Assay Kit, Iceplex System

- Pathway: 510(k) (Traditional)
- Applicant: Primeradx
- Decided: Nov 29, 2013 after 91 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: 3 generations back to K923463 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130470: BD Max Cdiff Assay, BD Max Instrument, Geneohm Sciences Canada, Inc. (Bd Diagnostics) (2013) Summary page 4.

## Indications for use
The PrimeraDx ICEPlex® C. difficile Assay Is for the qualitative detection of the Clostridium difficile toxin B gene (tcdB gene) in nucleic acids purified from unpreserved liquid or soft human stool specimens from patients suspected of having C. difficile Infection (CDI). The ICEPlex C.difficile Assay Is intended to be used only on the ICEPlex® System, which integrates PCR-based amplification with capillary electrophoresis (CE) for the detection of amplification products. The assay is intended to aid in the diagnosis of CDI. Results should be considered in conjunction with patient clinical history.

Source page: https://510kreport.com/device/K132726
Methodology: https://510kreport.com/methodology