# K100101: GSP Neonatalgalt Kit, Model 3303-001U

- Pathway: 510(k) (Traditional)
- Applicant: Perkinelmer, Inc.
- Decided: Jun 11, 2010 after 149 days
- Product code: KQP (Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase)
- Device class: 2
- Regulation: 21 CFR 862.1315
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K950803 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950803: Isolab's Galactose-1-Phosphate Uridyl Tranferase Test Kits 800, 4000 Sample, Isolab, Inc. (1995) Summary page 1.

## Recalls of this device
- May 18, 2026 · Class II · Z-2713-2026: Reduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of run-QC failures and consequently delay the reporting of patient results.

## Indications for use
The GSP Neonatal GALT kit is intended for the quantitative determination of galactose-1-phosphate uridyl transferase (GALT) activity in blood specimens dried on filter paper as an aid in screening newborns for classical galactosemia caused by GALT deficiency using the GSPTM instrument.

Source page: https://510kreport.com/device/K100101
Methodology: https://510kreport.com/methodology