# K133652: GSP Neonatal Total Galactose Kit

- Pathway: 510(k) (Traditional)
- Applicant: Wallac Oy, A Subsidiary of Perkinelmer, Inc.
- Decided: Apr 28, 2014 after 152 days
- Product code: JIA (Enzymatic Methods, Galactose)
- Device class: 1
- Regulation: 21 CFR 862.1310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K990654 (1999). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071649: Neonatal Total Galactose Kit; Neontal Total Galactose Kit, Models 3029-0010 and 3029-110B, Wallac OY (2008) Summary page 1.

## Most influential descendants
- K190335: GSP Neonatal Total Galactose kit (2019), 0 descendants of its own

## Indications for use
The GSP Neonatal Total Galactose kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia using the GSP® instrument.

Source page: https://510kreport.com/device/K133652
Methodology: https://510kreport.com/methodology