# K091109: Xpert C. Difficile

- Pathway: 510(k) (Traditional)
- Applicant: Cepheid
- Decided: Jul 9, 2009 after 84 days
- Product code: LLH (Reagents, Clostridium Difficile Toxin)
- 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: 2 generations back to K923463 (1993). 3 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081920: BD Geneohm Cdiff Assay, Bd Diagnostics (Geneohm Sciences, Inc.) (2008) Summary page 1.
- (no number) C. difficile reference culture method followed with strain identification of all C. difficile isolates: named in the summary without a submission number

## Most influential descendants
- K100818: Illumigene C. Difficile, Illumipro-10 and Illumigene C. Difficile External Control Kit, Models 280050, 610172, 279920 (2010), 2 descendants of its own
- K110203: Xpert C. Difficle/Epi Assay (2011), 1 descendant of its own
- K110012: Illumigene C. Difficile, and Illumipro-10 (2011), 1 descendant of its own
- K123197: Verigene C. Difficile Nucleic Acid Test (CDF) (2012), 0 descendants of its own
- K113433: Simplexa C. Difficile Universal Direct (2012), 0 descendants of its own

## Indications for use
The Cepheid Xpert® C. difficile Assay, performed on the Cepheid GeneXpert® Dx System, is a qualitative in vitro diagnostic test for rapid detection of toxin B gene sequences from unformed (liquid or soft) stool specimens collected from patients suspected of having Clostridium difficile infection (CDI). The test utilizes automated real-time polymerase chain reaction (PCR) to detect toxin gene sequences associated with toxin producing C. difficile. The Xpert C. difficile Assay is intended as an aid in the diagnosis of CDI. Concomitant culture is necessary only if further typing or organism recovery is required.

Source page: https://510kreport.com/device/K091109
Methodology: https://510kreport.com/methodology