FDA Product Code OZE: Influenza A And Influenza B Multiplex Nucleic Acid Assay
Under FDA product code OZE, influenza A and B multiplex nucleic acid assay systems are cleared for the rapid molecular diagnosis of influenza.
These assays simultaneously detect and differentiate influenza A and influenza B from respiratory specimens using nucleic acid amplification technology, providing results within hours compared to days for viral culture and distinguishing influenza from other respiratory illnesses.
OZE devices are Class II medical devices, regulated under 21 CFR 866.3980 and reviewed by the FDA Microbiology panel.
Leading manufacturers include Centers For Disease Control and Prevention, Abbott Diagnostics Scarborough, Inc. and Quidel Corporation.
FDA 510(k) Cleared Influenza A And Influenza B Multiplex Nucleic Acid Assay Devices (Product Code OZE)
About Product Code OZE - Regulatory Context
510(k) Submission Activity
20 total 510(k) submissions under product code OZE since 2012, with 20 receiving FDA clearance (average review time: 74 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 OZE have taken an average of 176 days to reach a decision - up from 63 days historically. Manufacturers should account for longer review timelines in current project planning.
OZE devices are reviewed by the Microbiology panel. Browse all Microbiology devices →