# PQA: Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System

- Device class: 2; regulation: 21 CFR 866.3975; FDA's rule: 510(k) required
- FDA decisions: 13
- 510(k) review time 2021–2025: median 90 days (middle half 38–185)
- Recalls: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2016: 1
- 2019: 3
- 2021: 1
- 2022: 2
- 2023: 2
- 2024: 2
- 2026: 2

## Most-cited predicates
- DEN160001: BD MAX Vaginal Panel, BD MAX Instrument (2016), cited by 5
- K191957: BD MAX Vaginal Panel (2019), cited by 4
- K201017: BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit (2021), cited by 2
- K212213: Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System (2022), cited by 1
- K190472: Aptima CV/TV Assay (2019), cited by 1
- K190452: Aptima BV Assay (2019), cited by 1
- K221160: Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System (2022), cited by 1
- K223653: BD Vaginal Panel (2023), cited by 1

Source page: https://510kreport.com/product-code/PQA
Data by year (CSV): https://510kreport.com/product-code/PQA.csv