Product Classification

• Device: novel influenza a virus, a/h5 ns1 protein
• Regulation Description: Reagents for detection of specific novel influenza A viruses.
• Definition: Novel influenza A virus reagents are used to directly detect and differentiate novel influenza A virus specific nonstructural protein 1 (NS1) in human respiratory specimens or viral cultures. Detection and differentiation of specific NS1 protein 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.
• Physical State: OIVD
• Technical Method: Immunoassay using PDZ domains in intracellular receptors to capture influenza A/H5 NS1 protein
• Target Area: PDZ ligands (PL) of NS1 protein
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Product Code: OMS
• 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 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

Not Third Party Eligible