# PQW: Alpha-D-Galactosidase A (Gla) Newborn Screening Test System

- Device class: 2; regulation: 21 CFR 862.1488; FDA's rule: 510(k) required
- FDA decisions: 3
- 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
- 2018: 1
- 2019: 1

## Most-cited predicates
- DEN150035: SEEKER System (2017), cited by 1
- K173829: NeoLSD MSMS kit (2018), cited by 1

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