OZN · Class II · 21 CFR 866.3130

FDA Product Code OZN: C. Difficile Toxin Gene Amplification Assay

Clostridioides difficile is the leading cause of healthcare-associated infectious diarrhea. FDA product code OZN covers C. difficile toxin gene amplification assays for rapid molecular diagnosis.

These PCR-based assays detect toxin gene sequences — tcdA and/or tcdB — directly from stool specimens, providing same-day results for CDI diagnosis with sensitivity superior to toxin immunoassays and speed superior to toxigenic culture.

OZN devices are Class II medical devices, regulated under 21 CFR 866.3130 and reviewed by the FDA Microbiology panel.

Leading manufacturers include Roche Molecular Systems, Inc. and Cepheid.

3
Total
3
Cleared
125d
Avg days
2021
Since

List of C. Difficile Toxin Gene Amplification Assay devices cleared through 510(k)

3 devices
1–3 of 3
Cleared Feb 28, 2025
Xpert C. difficile/Epi
K243730
Cepheid
Microbiology · 87d
Cleared Oct 20, 2021
cobas Cdiff nucleic acid test for use on the cobas Liat System
K212427
Roche Molecular Systems, Inc.
Microbiology · 77d
Cleared Sep 09, 2021
cobas Cdiff nucleic acid test for use on the cobas Liat System
K210385
Roche Molecular Systems, Inc.
Microbiology · 212d

How to use this database

This page lists all FDA 510(k) submissions for C. Difficile Toxin Gene Amplification Assay devices (product code OZN). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Microbiology FDA review panel. Browse all Microbiology devices →