FDA Product Code OCC: Respiratory Virus Panel Nucleic Acid Assay System
Under FDA product code OCC, respiratory virus panel nucleic acid assay systems are cleared for multiplex detection of respiratory viral pathogens.
These assays simultaneously identify multiple common respiratory viruses — including influenza A/B, RSV, parainfluenza, adenovirus, and human metapneumovirus — from a single respiratory specimen, enabling rapid and comprehensive viral diagnosis for patient cohorting and treatment decisions.
OCC devices are Class II medical devices, regulated under 21 CFR 866.3980 and reviewed by the FDA Microbiology panel.
Leading manufacturers include Roche Molecular Systems, Inc., Hologic, Inc. and Luminex Molecular Diagnostics, Inc..
FDA 510(k) Cleared Respiratory Virus Panel Nucleic Acid Assay System Devices (Product Code OCC)
About Product Code OCC - Regulatory Context
510(k) Submission Activity
79 total 510(k) submissions under product code OCC since 2008, with 78 receiving FDA clearance (average review time: 97 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 3 in the prior period.
FDA Review Time
Recent submissions under OCC have taken an average of 80 days to reach a decision - down from 98 days historically, suggesting improved FDA processing for this classification.
OCC devices are reviewed by the Microbiology panel. Browse all Microbiology devices →