# PRB: Cervical Intraepithelial Neoplasia (Cin) Test System

- Device class: 2; regulation: 21 CFR 864.1865; FDA's rule: 510(k) required
- FDA decisions: 2
- 510(k) review time 2021–2025: median 151 days (middle half 151–151)
- 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

## Most-cited predicates
- DEN160019: CINtec Histology (50 tests), CINtec Histology (250 tests) (2017), cited by 1

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