Product Classification

• Device: c. difficile toxin gene amplification assay
• Regulation Description: Clostridium difficile toxin gene amplification assay.
• Definition: Amplification assay for the detection of c. Difficile toxin genes from stool specimens of symptomatic patients.
• Physical State: Not applicable
• Technical Method: Uses amplification technology to detect toxin genes of C. difficile
• Target Area: Not applicable
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Product Code: OZN
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Microbiology Devices (DMD)
• Submission Type: 510(k)
• Regulation Number: 866.3130
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Guidance Document

• Class II Special Controls Guideline Document: Toxin Gene Amplification Assays for the Detection of Clostridium difficile - Guideline for Industry and Food and Drug Administration Staff

Third Party Review

Not Third Party Eligible