Product Classification

• Device: assayed external control material for microbiology nucleic acid amplification (nat) assays
• Regulation Description: Assayed quality control material for clinical microbiology assays.
• Definition: Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use.
• Physical State: solid or liquid
• Technical Method: For use with nucleic acid amplification microbiology assays
• Target Area: Not applicable - Single or multi-analyte
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Product Code: PMN
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Microbiology Devices (DMD)
• Submission Type: 510(k)
• Regulation Number: 866.3920
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• global quality and regulatory services
• regulatory technology services, llc