# K123197: Verigene C. Difficile Nucleic Acid Test (CDF)

- Pathway: 510(k) (Traditional)
- Applicant: Nanosphere, Inc.
- Decided: Dec 5, 2012 after 55 days
- Product code: OZN (C. Difficile Toxin Gene Amplification Assay)
- Device class: 2
- Regulation: 21 CFR 866.3130
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN070013 (2008). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN120013: C. Difficile Nucleic Acid Amplification Test Assay. Our reading of the summary gave K113358, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN120013, C. Difficile Nucleic Acid Amplification Test Assay (), granted —; older De Novo requests were first filed under a 510(k) number, so this links to the grant.
- K110203: Xpert C. Difficle/Epi Assay, Cepheid (2011) Summary page 2.
- K092566: Verigene Respiratory Virus Nucleic Acid Test on the Verigene SP System (Rvnatsp), Nanosphere, Inc. (2009) Summary page 2.

## Recalls of this device
- Jun 5, 2023 · Class II · Z-2024-2023: It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Part No. 20-005-023) could provide a false-
- Oct 30, 2020 · Class II · Z-2010-2021: Potential for a false-negative result.
- Oct 16, 2013 · Class III · Z-2168-2014: Nanosphere has received report of an increased rate of "No Call - INT CTL 2" results for the Internal Control 2 (INT CTL 2) when negative samples are tested with certain lots of CDF Amplification Tray
- Oct 10, 2013 · Class II · Z-2682-2014: Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed on the Processor SP caused by Tips in Tip Holder Assemblies for the following pro

## Indications for use
The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). Presumptive identification of the PCR ribotype 027 strain of C. difficile is by detection of the binary toxin (cdt) gene sequence and the single base pair deletion at nucleotide 117 in the tcdC gene. The tcdC gene encodes for a negative regulator in C. difficile toxin production. The test is performed on the Verigene System and utilizes automated specimen preparation and polymerase chain reaction (PCR) amplification, combined with a nanoparticle-based array hybridization assay to detect the toxin gene sequences associated with toxin-producing C. difficile. The CDF Test is indicated for use as an aid in the diagnosis of CDI. Detection of PCR ribotype 027 strains of C. difficile by the CDF Test 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/K123197
Methodology: https://510kreport.com/methodology