# JIA: Enzymatic Methods, Galactose

- Device class: 1; regulation: 21 CFR 862.1310; FDA's rule: 510(k) required
- FDA decisions: 9
- Recalls: 6 (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)
- 1995: 1
- 1996: 1
- 1999: 3
- 2008: 1
- 2013: 1
- 2014: 1
- 2019: 1

## Most-cited predicates
- K071649: Neonatal Total Galactose Kit; Neontal Total Galactose Kit, Models 3029-0010 and 3029-110B (2008), cited by 1
- K991498: Accuwell Total Galactose, Model 6010-Egal (1999), cited by 1
- K133652: GSP Neonatal Total Galactose Kit (2014), cited by 1
- K990654: Quantase Total Galactose Screening Assay 500 Test Kit (1999), cited by 1

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