# PRE: Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers

- Device class: 2; regulation: 21 CFR 866.3215; FDA's rule: 510(k) required
- FDA decisions: 4
- 510(k) review time 2021–2025: median 213 days (middle half 184–277)
- 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)
- 2017: 1
- 2021: 1
- 2023: 1
- 2025: 1

## Most-cited predicates
- K203748: SeptiCyte RAPID (2021), cited by 1
- K163260: SeptiCyte LAB (2017), cited by 1

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