# K172569: GenePOC CDiff

- Pathway: 510(k) (Traditional)
- Applicant: Genepoc, Inc.
- Decided: Nov 22, 2017 after 89 days
- Product code: OZN (C. Difficile Toxin Gene Amplification Assay)
- Device class: 2
- Regulation: 21 CFR 866.3130
- Recalls of this device: 1 (0 Class I)
- 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)
- K130470: BD Max Cdiff Assay, BD Max Instrument, Geneohm Sciences Canada, Inc. (Bd Diagnostics) (2013) Summary page 6.

## Most influential descendants
- K232092: Great Basin Toxigenic C. difficile Direct Test (CDF2) (2023), 0 descendants of its own

## Recalls of this device
- Dec 5, 2025 · Class II · Z-1019-2026: The affected lots show a decline in performance over time, which may lead to false-negative results.

## Indications for use
The GenePOC CDiff assay performed on the revogene instrument is a qualitative in vitro diagnostic test that utilizes automated sample processing and real-time polymerase chain reaction (PCR) to detect the toxin B (tcdB) gene of toxigenic Clostridium difficile (C. difficile) in unformed (liquid or soft) stool specimens obtained from patients suspected of having C. difficile infection (CDI). The GenePOC CDiff assay is intended to aid in the diagnosis of CDI.

Source page: https://510kreport.com/device/K172569
Methodology: https://510kreport.com/methodology