# K113433: Simplexa C. Difficile Universal Direct

- Pathway: 510(k) (Traditional)
- Applicant: Focus Diagnostics, Inc.
- Decided: Apr 4, 2012 after 135 days
- Product code: OMN (C. Difficile Nucleic Acid Amplification Test Assay)
- Device class: 1
- Regulation: 21 CFR 866.2660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K923463 (1993). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110012: Illumigene C. Difficile, and Illumipro-10, Meridian Bioscience, Inc. (2011) Summary page 1.
- K081920: BD Geneohm Cdiff Assay, Bd Diagnostics (Geneohm Sciences, Inc.) (2008) Summary page 1.

## Indications for use
The Focus Diagnostics SimplexaTM C. dtfficile Universal Direct is a real-time polymerase chain reaction (PCR) assay and is intended for use on the 3M Integrated Cycler instrument for the detection of toiigenic Clostridium dificile toxin B gene (tcdB) in liquid or unformed stool samples from individuals suspected of C. difficile infection. This test aids in the diagnosis of Clostridium difficile associated disease (CDAD).

Source page: https://510kreport.com/device/K113433
Methodology: https://510kreport.com/methodology