# K121101: Spotcheck Neonatal Total Galactose Microplate Reagent Kit

- Pathway: 510(k) (Traditional)
- Applicant: Astoria-Pacific, Inc.
- Decided: Jun 20, 2013 after 435 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: 1 generation back to K991498 (1999). 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)
- K991498: Accuwell Total Galactose, Model 6010-Egal, Neometrics, Inc. (1999) Summary page 2.

## Indications for use
The SPOTCHECK® Neonatal Total Galactose Microplate Reagent Kit is for the quantitative determination of the concentration of Total Galactose (galactose (Gal) + galactose-1-phosphate (Gal-1-P)) in whole blood saturated filter paper disks, using a microplate absorbance reader or SPOTCHECK Pro. Measurements of Total Galactose are used primarily in the diagnosis and treatment of the hereditary disease galactosemia. This method is intended for in vitro diagnostic use as an aid in neonatal screening for increased concentrations of Total Galactose, and not for monitoring purposes.

Source page: https://510kreport.com/device/K121101
Methodology: https://510kreport.com/methodology