# K990654: Quantase Total Galactose Screening Assay 500 Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Quantase, Ltd.
- Decided: Jun 21, 1999 after 112 days
- Product code: JIA (Enzymatic Methods, Galactose)
- Device class: 1
- Regulation: 21 CFR 862.1310
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K071649: Neonatal Total Galactose Kit; Neontal Total Galactose Kit, Models 3029-0010 and 3029-110B (2008), 2 descendants of its own
- K133652: GSP Neonatal Total Galactose Kit (2014), 1 descendant of its own
- K190335: GSP Neonatal Total Galactose kit (2019), 0 descendants of its own

## Recalls of this device
- Jan 26, 2010 · Not classified · Z-1562-2011: Pressure contained within the Elution Buffer vial may expel the rubber stopper, causing the potential for injury.

## Indications for use
The Quantase Total Galactose Screening Assay is an enzymatic colorimetiic o -point method for the determination of total D(+)galactose (D(+)galactose + galactose-1-phosphate) in dried blood spot specimens taken from newborn human infants as part of a newbom screening programme. The test is intended as a screening method for measuring the total D(+)galactose concentrations in newborn blood spot specimens. Elevated results are not diagnostic per se of galactosaemia, but indicate the urgent need for further study of the newborn from which the presumptive positive specimen was received. The kit is NOT intended for use in monitoring the circulating concentrations of total D(+)galactose in galactosaemic patients nor to detect ante-natal galactosaemia.

Source page: https://510kreport.com/device/K990654
Methodology: https://510kreport.com/methodology