# K110203: Xpert C. Difficle/Epi Assay

- Pathway: 510(k) (Traditional)
- Applicant: Cepheid
- Decided: Apr 7, 2011 after 73 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: 3 generations back to K923463 (1993). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091109: Xpert C. Difficile, Cepheid (2009). Our reading of the summary gave K001109, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Cepheid Xpert C. difficile Assay”. Summary page 5.
- K081920: BD Geneohm Cdiff Assay, Bd Diagnostics (Geneohm Sciences, Inc.) (2008) Summary page 4.

## Most influential descendants
- K123197: Verigene C. Difficile Nucleic Acid Test (CDF) (2012), 0 descendants of its own

## Indications for use
The Cepheid Xpert® C. difficile/Epi Assay is a qualitative in vitro diagnostic test for rapid detection of toxin B gene sequences and for presumptive identification of 027/NAP 1/131 strains of toxigenic Clostridium dificile from unformed (liquid or soft) stool specimens collected from patients suspected of having C. cifficile infection (CDI). Presumptive identification of 027/NAPI/BI strains of C. difficile is by detection of binary toxin (CDT) gene sequences and the single base pair deletion at nucleotide 117 in the tedC gene. The tcdC gene encodes for a negative regulator in C. difficile toxin production. The test is performed on the Cepheid GeneXpertV Dx System and utilizes automated real-time polymerase chain reaction (PCR) to detect toxin gene sequences associated with toxin producing C. difficile. The Xpert C. difficile/Epi Assay is intended as an aid in the diagnosis of CDI. Detection of 027/NAP]I fBl strains of C. difficile by the Xpert C. dificile/Epi Assay is presumptive and is solely for epidemiological purposes and is not intended to guide or monitor treatment for C. difficile infections. Concomitant culture is necessary only if further typing or organism recovery is required.

Source page: https://510kreport.com/device/K110203
Methodology: https://510kreport.com/methodology