FDA Product Code QQX: Respiratory Specimen Nucleic Acid Sars-cov-2 Test
Under FDA product code QQX, respiratory specimen nucleic acid tests for SARS-CoV-2 are cleared for the molecular diagnosis of COVID-19.
These PCR-based or isothermal amplification assays detect SARS-CoV-2 RNA in nasopharyngeal, nasal, or saliva specimens with high sensitivity and specificity. They are used in clinical laboratories for COVID-19 diagnosis and surveillance.
QQX devices are Class II medical devices, regulated under 21 CFR 866.3981 and reviewed by the FDA Microbiology panel.
Leading manufacturers include Roche Molecular Systems, Inc., Cepheid and Life Technologies Corporation.
FDA 510(k) Cleared Respiratory Specimen Nucleic Acid Sars-cov-2 Test Devices (Product Code QQX)
About Product Code QQX - Regulatory Context
510(k) Submission Activity
11 total 510(k) submissions under product code QQX since 2021, with 11 receiving FDA clearance (average review time: 212 days).
Submission volume has remained relatively stable over the observed period, with 5 submissions in the last 24 months.
FDA Review Time
FDA review times for QQX submissions have been consistent, averaging 211 days recently vs 214 days historically.
QQX devices are reviewed by the Microbiology panel. Browse all Microbiology devices →