# K163085: Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack

- Pathway: 510(k) (Traditional)
- Applicant: Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC
- Decided: Feb 14, 2017 after 103 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 Focus Diagnostics Simplexa™ C. difficile Direct assay is intended for use on the Integrated Cycler instrument for the detection of Clostridium difficile toxin B gene (tcdB) present in liquid or unformed stool samples from individuals suspected of C. difficile infection (CDI). This test aids in the diagnosis of illness resulting from CDI. The assay is for professional and prescription use only. The Simplexa™ C. difficile Positive Control Pack is intended to be used as a control with the Simplexa™ C. difficile Direct kit. This control is not intended for use with other assays or systems.

Source page: https://510kreport.com/device/K163085
Methodology: https://510kreport.com/methodology