Code of Federal Regulations Title 21. Food and Drugs § 21.866.3980 Respiratory viral panel multiplex nucleic acid assay

(1) Influenza A and Influenza B;

(2) Influenza A subtype H1 and Influenza A subtype H3;

(3) Respiratory Syncytial Virus subtype A and Respiratory Syncytial Virus subtype B;

(4) Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus;

(5) Human Metapneumovirus;

(6) Rhinovirus;  and

(7) Adenovirus.

(1) FDA's guidance document entitled “Class II Special Controls Guidance Document:  Respiratory Viral Panel Multiplex Nucleic Acid Assay;”

(2) For a device that detects and identifies Human Metapneumovirus, FDA's guidance document entitled “Class II Special Controls Guidance Document:  Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays;”  and

(3) For a device that detects and differentiates Influenza A subtype H1 and subtype H3, FDA's guidance document entitled “Class II Special Controls Guidance Document:  Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Nucleic Acid Assays.” See § 866.1(e) for the availability of these guidance documents.