# K990644: Quantase Total Galactose Screening Assay

- Pathway: 510(k) (Traditional)
- Applicant: Quantase, Ltd.
- Decided: Jun 21, 1999 after 115 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## 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 colorimetric end-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/K990644
Methodology: https://510kreport.com/methodology