# K210385: cobas Cdiff nucleic acid test for use on the cobas Liat System

- Pathway: 510(k) (Special)
- Applicant: Roche Molecular Systems, Inc.
- Decided: Sep 9, 2021 after 212 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: 5 generations back to K923463 (1993). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171770: cobas Cdiff Nucleic acid test for use on the cobas Liat System, Roche Molecular Systems, Inc. (2017) Summary page 6.

## Indications for use
The cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System is an automated, qualitative in vitro diagnostic test that uses real-time polymerase chain reaction (PCR) for the detection of the toxin B (tcdB) gene of toxigenic Clostridioides difficile (C.difficile) in unformed (liquid or soft) stool specimens obtained from patients suspected of having C. difficile infection (CDI). The cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System 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/K210385
Methodology: https://510kreport.com/methodology