# PZJ: Lynch Syndrome Test System

- Device class: 2; regulation: 21 CFR 864.1866; FDA's rule: 510(k) required
- FDA decisions: 5
- 510(k) review time 2021–2025: median 552 days (middle half 527–615)
- 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: 2
- 2026: 1

## Most-cited predicates
- DEN170030: VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH2 (G219-1129)  Mouse Monoclonal Primary Antibody, VENTANA anti-MSH6 (SP 93) Mouse Monoclonal Primary Antibody, VENTANA anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody (2017), cited by 2
- K200129: OncoMate MSI Dx Analysis System (2021), cited by 1

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