# PRI: Procalcitonin Assay

- Device class: 2; regulation: 21 CFR 866.3215; FDA's rule: 510(k) required
- FDA decisions: 8
- 510(k) review time 2021–2025: median 207 days (middle half 207–207)
- Recalls: 1 (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)
- 2017: 4
- 2018: 2
- 2020: 1
- 2022: 1

## Most-cited predicates
- K171338: B R A H M S PCT sensitive KRYPTOR (2017), cited by 6
- K162827: Vidas B.R.a.H.M.S. PCT (PCT) (2017), cited by 6
- K173927: Elecsys BRAHMS PCT (2018), cited by 1

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