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., Quidel Corporation and Cepheid.

18
Total
18
Cleared
106d
Avg days
2012
Since
Growing category - 2 submissions in the last 2 years vs 1 in the prior period
Review times increasing: avg 160d recently vs 100d historically

FDA 510(k) Cleared C. Difficile Toxin Gene Amplification Assay Devices (Product Code OZN)

18 devices
1–18 of 18
Cleared Aug 28, 2026
cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190)
K260045
Roche Molecular Systems, Inc.
Microbiology · 233d
Cleared Feb 28, 2025
Xpert C. difficile/Epi
K243730
Cepheid
Microbiology · 87d
Cleared Nov 14, 2023
Great Basin Toxigenic C. difficile Direct Test (CDF2)
K232092
Vela Operations USA
Microbiology · 124d
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
Cleared Nov 22, 2017
GenePOC CDiff
K172569
Genepoc, Inc.
Microbiology · 89d
Cleared Sep 12, 2017
cobas Cdiff Nucleic acid test for use on the cobas Liat System
K171770
Roche Molecular Systems, Inc.
Microbiology · 90d
Cleared Jul 21, 2017
ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit
K171441
Luminex Corporation
Microbiology · 66d
Cleared May 11, 2017
Solana C. difficile Assay
K170491
Quidel Corporation
Microbiology · 83d
Cleared Feb 14, 2017
Simplexa C. difficile Direct
K163085
Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC
Microbiology · 103d
Cleared May 20, 2015
cobas Cdiff Test
K142422
Roche Molecular Systems, Inc.
Microbiology · 265d
Cleared Apr 04, 2014
ARTUS C. DIFFICILE QS-RGQ MDX KIT
K133936
QIAGEN GmbH
Microbiology · 102d
Cleared Nov 29, 2013
ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM
K132726
Primeradx
Microbiology · 91d
Cleared Oct 11, 2013
IMDX C.DIFFICILE FOR ABBOTT M2000
K132235
Intelligent Medical Devices, Inc.
Microbiology · 85d
Cleared Apr 02, 2013
BD MAX CDIFF ASSAY, BD MAX INSTRUMENT
K130470
Geneohm Sciences Canada, Inc. (Bd Diagnostics)
Microbiology · 36d
Cleared Mar 08, 2013
QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY
K123998
Quidel Corp.
Microbiology · 72d
Cleared Dec 13, 2012
AMPLIVUE C. DIFFICILE ASSAY
K123355
Quidel Corporation
Microbiology · 43d
Cleared Dec 05, 2012
VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)
K123197
Nanosphere, Inc.
Microbiology · 55d

About Product Code OZN - Regulatory Context

510(k) Submission Activity

18 total 510(k) submissions under product code OZN since 2012, with 18 receiving FDA clearance (average review time: 106 days).

Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - OZN Product Code

Recent submissions under OZN have taken an average of 160 days to reach a decision - up from 100 days historically. Manufacturers should account for longer review timelines in current project planning.

OZN devices are reviewed by the Microbiology panel. Browse all Microbiology devices →