FDA Product Code PQA: Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
Vaginitis is among the most common reasons women seek gynecological care. FDA product code PQA covers molecular tests for the simultaneous detection and differentiation of vaginitis pathogens and bacterial vaginosis.
These multiplex nucleic acid assays identify Candida species, Trichomonas vaginalis, Gardnerella vaginalis, and other causative organisms from a single vaginal swab, replacing culture and wet mount with a faster and more sensitive molecular result.
PQA devices are Class II medical devices, regulated under 21 CFR 866.3975 and reviewed by the FDA Microbiology panel.
Leading manufacturers include Cepheid, Becton, Dickinson and Company and Hologic, Inc..
FDA 510(k) Cleared Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System Devices (Product Code PQA)
About Product Code PQA - Regulatory Context
510(k) Submission Activity
11 total 510(k) submissions under product code PQA since 2016, with 10 receiving FDA clearance (average review time: 150 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 PQA have taken an average of 22 days to reach a decision - down from 178 days historically, suggesting improved FDA processing for this classification.
PQA devices are reviewed by the Microbiology panel. Browse all Microbiology devices →