# PJI: Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System

- Device class: 2; regulation: 21 CFR 866.5930; FDA's rule: 510(k) required
- FDA decisions: 2
- 510(k) review time 2021–2025: median 765 days (middle half 765–765)
- 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)
- 2014: 1
- 2022: 1

## Most-cited predicates
- DEN140010: Perkinelmer Enlite Neonatal Trec Test System (2014), cited by 1

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