# K190335: GSP Neonatal Total Galactose kit

- Pathway: 510(k) (Traditional)
- Applicant: Perkinelmer, Inc.
- Decided: Nov 6, 2019 after 265 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: 3 generations back to K990654 (1999). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133652: GSP Neonatal Total Galactose Kit, Wallac Oy, A Subsidiary of Perkinelmer, Inc. (2014) Summary page 4.

## 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/K190335
Methodology: https://510kreport.com/methodology