# QEP: Nucleic Acid Detection System For Non-Viral Microorganism (S) Causing Sexually Transmitted Infections

- Device class: 2; regulation: 21 CFR 866.3393; FDA's rule: 510(k) required
- FDA decisions: 24
- 510(k) review time 2021–2025: median 357 days (middle half 179–438)
- Recalls: 3 (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)
- 2019: 5
- 2020: 3
- 2021: 3
- 2022: 3
- 2023: 3
- 2025: 4
- 2026: 3

## Most-cited predicates
- DEN180047: Aptima Mycoplasma genitalium Assay (2019), cited by 4
- K190433: cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit (2019), cited by 3
- K202408: cobas CTNG for use on cobas 6800/8800 systems (2021), cited by 3
- K190515: Aptima Combo 2 Assay (Panther System) (2019), cited by 3
- K191352: binx health io CT/NG Assay (2019), cited by 1
- K210585: BD CTGCTV2 (2022), cited by 1
- K200436: Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test kit, Aptima Trichomonas Vaginalis (Panther) - 250 test kit, Aptima Trichomonas Vaginalis (Tigris) - 250 test kit (2020), cited by 1
- K200748: Visby Medical Sexual Health (2021), cited by 1
- K202977: Alinity m STI Assay (2022), cited by 1
- K220407: Visby Medical Sexual Health Test (2023), cited by 1

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