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.
FDA 510(k) Cleared C. Difficile Toxin Gene Amplification Assay Devices (Product Code OZN)
About Product Code OZN - Regulatory Context
510(k) Submission Activity
17 total 510(k) submissions under product code OZN since 2012, with 17 receiving FDA clearance (average review time: 99 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
FDA review times for OZN submissions have been consistent, averaging 87 days recently vs 100 days historically.
OZN devices are reviewed by the Microbiology panel. Browse all Microbiology devices →