# PTA: Genetic Variant Detection And Health Risk Assessment System

- Device class: 2; regulation: 21 CFR 866.5950; FDA's rule: 510(k) exempt
- FDA decisions: 5
- 510(k) review time 2021–2025: median 197 days (middle half 181–214)
- Recalls: 0 (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)
- 2020: 2
- 2022: 1
- 2025: 1

## Most-cited predicates
- DEN160026: Genetic Variant Detection And Health Risk Assessment System (), cited by 3

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