Product Classification

• Device: influenza a virus subtype differentiation nucleic acid assay
• Regulation Description: Respiratory viral panel multiplex nucleic acid assay.
• Definition: A qualitative in vitro diagnostic assay intended to detect and differentiate between influenza a virus subtypes in human respiratory specimens or viral culture.Detection and differentiation of specific subtype rna aids in the diagnosis of influenza caused by influenza a in conjunction with other clinical and laboratory testing in patients suspected of being infected with these viruses.Also, it aids in the presumptive laboratory identification of influenza a virus subtypes to provide epidemiological information on influenza.
• Physical State: OIVD
• Technical Method: Direct nucleic acid detection
• Target Area: Specific RNA segments
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Product Code: OEP
• Submission Type: 510(k)
• Regulation Number: 866.3980
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Guidance Documents

• Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Assays  
• Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay  

Third Party Review

Not Third Party Eligible