# K970277: Uridyltransferase Kit, 50 Hour (80-4000-13K)

- Pathway: 510(k) (Traditional)
- Applicant: Astoria-Pacific, Inc.
- Decided: Dec 11, 1997 after 322 days
- Product code: KQP (Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase)
- Device class: 2
- Regulation: 21 CFR 862.1315
- 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. The FDA summary names its predicate without a number.
- (no number) Sigma Galactose-1-Phosphate Uridyltransferase (Gal-PUT) Deficiency Screen: named in the summary without a submission number

## Recalls of this device
- Mar 5, 2015 · Class II · Z-1659-2015: The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both IMMULITE 2000 and IMMULITE 2000XPi Water Bottles and Liquid Waste Bottles is under

## Indications for use
This Astoria-Pacific SPOTCHECK® Uridyltransferase 50-Hour Reagent Kit is for the gqualitative determination of galactose-1-phosphate uridyltransferase (EC 2.7.7.12) (GALT) activity in whole blood saturated filter paper disks, S&S 983 filter paper or equivalent, using the AP1 ™ 308 SPOTCHECK® Analyzer or the RFA-jed System. Measurements of galactose-1-phosphate uridgltransferase are used in the diagnosis and treatment of the hereditary disease galactosemia. This method is intended for in vitro diagnostic use as an aid in screening for decreased levels of GALT enzyme activity in infants. This method is not for monitoring purposes.

Source page: https://510kreport.com/device/K970277
Methodology: https://510kreport.com/methodology