FDA Product Code QOF: Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents
FDA product code QOF covers multi-target respiratory specimen nucleic acid tests.
These multiplex molecular assays simultaneously detect and identify multiple respiratory pathogens — including influenza A/B, RSV, SARS-CoV-2, and others — from a single patient sample. They provide faster and more comprehensive results than single-target tests, enabling rapid differentiation of respiratory illnesses.
QOF devices are Class II medical devices, regulated under 21 CFR 866.3981 and reviewed by the FDA Microbiology panel.
Leading manufacturers include Biofire Diagnostics, LLC, Roche Molecular Systems, Inc. and Cepheid.
FDA 510(k) Cleared Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents Devices (Product Code QOF)
About Product Code QOF - Regulatory Context
510(k) Submission Activity
31 total 510(k) submissions under product code QOF since 2021, with 30 receiving FDA clearance (average review time: 180 days).
Submission volume has increased in recent years - 19 submissions in the last 24 months compared to 11 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under QOF have taken an average of 157 days to reach a decision - down from 218 days historically, suggesting improved FDA processing for this classification.
QOF devices are reviewed by the Microbiology panel. Browse all Microbiology devices →