# K142422: cobas Cdiff Test

- Pathway: 510(k) (Traditional)
- Applicant: Roche Molecular Systems, Inc.
- Decided: May 20, 2015 after 265 days
- Product code: OZN (C. Difficile Toxin Gene Amplification Assay)
- Device class: 2
- Regulation: 21 CFR 866.3130
- 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.
5 later devices descend from it; 1 cites it directly.
0 of 10 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 4.

## Most influential descendants
- 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
- K260045: cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas® Cdiff Positive and Negative Control Kit for use on the cobas® Liat® System (07454970190) (2026), 0 descendants of its own
- K243730: Xpert C. difficile/Epi (2025), 0 descendants of its own
- K210385: cobas Cdiff nucleic acid test for use on the cobas Liat System (2021), 0 descendants of its own

## Indications for use
The cobas® Cdiff Test on the cobas® 4800 system is an automated, qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection of 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 cobas® Cdiff Test is intended for use as an aid in the diagnosis of CDI in humans in conjunction with clinical and epidemiological risk factors.

Source page: https://510kreport.com/device/K142422
Methodology: https://510kreport.com/methodology