# K984463: Quantase Phe/Gal Screening Assay

- Pathway: 510(k) (Traditional)
- Applicant: Quantase, Ltd.
- Decided: Feb 16, 1999 after 62 days
- Product code: JNB (Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine)
- Device class: 2
- Regulation: 21 CFR 862.1555
- Recalls of this device: none
- 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.

## Indications for use
The Quantase Phe/Gal Screening Assay is an enzymatic colorimetric end-point method for the determination of L-phenylalanine and total D(+)galactose (D(+)galactose + galactose-1-phosphate) in dried blood spot specimens taken from newborn human infants as part of a newborn screening program. The test is intended as a screening method for measuring the L-phenylalanine and total D(+)galactose concentrations in newborn blood spot specimens. Elevated results are not diagnostic per se of phenylketonuria or galactosemia, but indicate a current need for further study of the newborn from which the positive specimen was received. The test is NOT for use in monitoring the circulating levels of phenylalanine and total D(+)galactose in phenylketonuric and galactosemic patients respectively, nor to detect ante-natal phenylketonuria and galactosemia or maternal phenylketonuria.

Source page: https://510kreport.com/device/K984463
Methodology: https://510kreport.com/methodology