# K081920: BD Geneohm Cdiff Assay

- Pathway: 510(k) (Traditional)
- Applicant: Bd Diagnostics (Geneohm Sciences, Inc.)
- Decided: Dec 19, 2008 after 169 days
- Product code: LLH (Reagents, Clostridium Difficile Toxin)
- Device class: 1
- Regulation: 21 CFR 866.2660
- 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: 1 generation back to K923463 (1993). 2 ancestors in all.
18 later devices descend from it; 5 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935296: Clostridium Difficile Tox-B Test, Techlab, Inc. (1994) Summary page 1.
- K923463: Clostridium Difficile Toxin/Antitoxin Kit, Techlab, Inc. (1993) Summary page 1.

## Most influential descendants
- K130470: BD Max Cdiff Assay, BD Max Instrument (2013), 10 descendants of its own
- K142422: cobas Cdiff Test (2015), 5 descendants of its own
- K091109: Xpert C. Difficile (2009), 5 descendants of its own
- K171770: cobas Cdiff Nucleic acid test for use on the cobas Liat System (2017), 4 descendants of its own
- K212427: cobas Cdiff nucleic acid test for use on the cobas Liat System (2021), 2 descendants of its own

## Recalls of this device
- Oct 11, 2013 · Class II · Z-0790-2014: An incorrect reagent was packed with an in vitro diagnostic kit, which may cause an increase in unresolved results or false negative results for Clostridium difficile in patient samples.
- May 22, 2012 · Class II · Z-2319-2012: Leakage in Cepheid SmartCycler reaction tubes.
- May 22, 2012 · Class II · Z-2318-2012: Leakage in Cepheid SmartCycler reaction tubes.
- Mar 5, 2010 · Not classified · Z-2174-2010: In vitro diagnostic test kits do not perform to specifications.

## Indications for use
The BD GeneOhm TM Cdiff Assay is a rapid in vitro diagnostic test for the direct, qualitative detection of C. difficile toxin B gene (tcdB) in human liquid or soft stool specimens from patients suspected of having Clostridium difficile-associated disease (CDAD). The test, based on real-time PCR, is intended for use as an aid in diagnosis of CDAD. The test is performed directly on the specimen, utilizing polymerase chain reaction (PCR) for the amplification of specific targets and fluorogenic target-specific hybridization probes for the detection of the amplified DNA.

Source page: https://510kreport.com/device/K081920
Methodology: https://510kreport.com/methodology