Product Classification

• Device: nucleic acid amplification, novel influenza a virus, a/h5 (asian lineage) rna
• Regulation Description: Reagents for detection of specific novel influenza A viruses.
• Definition: Novel influenza a virus reagents are used in nucleic acid amplification tests to directly detect and differentiate novel influenza a virus specific rna gene segments in human respiratory specimens or viral cultures. Detection and differentiation of specific rna gene segments aids in the diagnosis of influenza caused by novel influenza a viruses in patients with clinical and epidemiological risk of infection with these viruses. They also aid in the presumptive identification of specific novel influenza a viruses and provide epidemiological information on influenza. These reagents are primers and probes, along with a specific novel influenza virus control.
• Physical State: OIVD
• Technical Method: Direct nucleic acid amplification
• Target Area: specific RNA segment
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Product Code: NXD
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Microbiology Devices (DMD)
• Submission Type: 510(k)
• Regulation Number: 866.3332
• 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

Guidance Documents

• 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

• Reagents for Detection of Specific Novel Influenza A Viruses : Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document

Third Party Review

Not Third Party Eligible