Medical devices; immunology and microbiology devices; classification of respiratory viral panel multiplex nucleic acid assay. Final rule.
The Food and Drug Administration (FDA) is announcing the classification of the respiratory viral panel multiplex nucleic acid assay into class II (special controls). The special controls that will apply to the device are three guidance documents entitled: "Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay," as applicable, "Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays," and as applicable,"Class II Special Controls Guidance Document: Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Nucleic Acid Assays.'' The agency classified the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance documents that will serve as the special controls for this device.
D018795:Device Approval; D004869:Equipment Safety / Q000145:classification; D006801:Humans; D009980:Influenza A virus / Q000145:classification*; D007251:Influenza, Human / Q000145:classification* / Q000175:diagnosis; D021141:Nucleic Acid Amplification Techniques / Q000145:classification* / Q000295:instrumentation; D009696:Nucleic Acids; D012367:RNA, Viral; D012141:Respiratory Tract Infections / Q000145:classification* / Q000175:diagnosis / Q000821:virology; D014481:United States; D014486:United States Food and Drug Administration; D014773:Virology / Q000295:instrumentation*
D009696:Nucleic Acids; D012367:RNA, Viral