# K991498: Accuwell Total Galactose, Model 6010-Egal

- Pathway: 510(k) (Traditional)
- Applicant: Neometrics, Inc.
- Decided: Jun 16, 1999 after 48 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K121101: Spotcheck Neonatal Total Galactose Microplate Reagent Kit (2013), 0 descendants of its own

## Indications for use
Neometrics® ACCUWELL™ Total Galactose kits are intended to be used for the quantitative measurment of Total Galactose in neonatal dried blood spot samples which have been collected onto S&S grade 903 filter paper. Results are used to screen newborns for galactosemia.

Source page: https://510kreport.com/device/K991498
Methodology: https://510kreport.com/methodology