# PMT: Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens

- Device class: 2; regulation: 21 CFR 866.3215; FDA's rule: 510(k) required
- FDA decisions: 5
- 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)
- 2016: 3
- 2018: 1
- 2020: 1

## Most-cited predicates
- DEN150009: B.R.A.H.M.S PCT sensitive KRYPTOR (2016), cited by 5
- K160911: Vidas B.R.a.H.M.S. PCT (PCT) (2016), cited by 1

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