Product Classification

• Device: assay, direct, nucleic acid amplification, influenza virus
• Regulation Description: Influenza virus serological reagents.
• Definition: These reagents are nucleic acid primers and probes for the amplification and identification of Influenza virus directly from clinical specimens. The identification aids in the diagnosis of influenza and provides epidemiological information on this disease. This reagent differs from the description in the regulation in that it consists of nucleic acid primers and probes rather than antisera.
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Product Code: NIA
• Premarket Review: Division of Microbiology Devices (DMD); Division of Microbiology Devices (DMD)
• Submission Type: 510(k)
• Regulation Number: 866.3330
• Device Class: 1
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Guidance Document

• Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses - Guidance for Industry and FDA Staff

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

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