# K102643: Spotcheck Neonatal Galt Microplate Reagent Kit

- Pathway: 510(k) (Traditional)
- Applicant: Astoria-Pacific, Inc.
- Decided: Jul 15, 2011 after 304 days
- Product code: KQP (Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase)
- Device class: 2
- Regulation: 21 CFR 862.1315
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K961432 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990827: Microplate Neonatal Galt Assay, Bio-Rad (1999) Summary page 2.
- K953710: ELX808 Automated Microplate Readers, Bio-Tek Instruments, Inc. (1995) Summary page 2.

## Indications for use
The SPOTCHECK Neonatal GALT Microplate Reagent Kit is for the quantitative determination of galactose-1 -phosphate uridyltransferase, EC 2.7.7.12 (GALT), activity in whole blood saturated filter paper disks, using a microplate absorbance reader. Measurements of GALT enzyme activity are used primarily in the diagnosis and treatment of the hereditary disease galactosemia. This method is intended for in vitro diagnostic use as an aid in neonatal screening for decreased levels of GALT enzyme activity, and not for monitoring purposes. This device is intended for use by trained, qualified laboratory personnel. The SPOTCHECK Pro is used for automated sample processing in the application of in vitro diagnostic assays. Specimens containing patient bodily substances are introduced and analyzed in microtiter plates using qualitative/quantitative determination through absorbance measurements. This device and assays are intended for use by trained, qualified laboratory personnel.

Source page: https://510kreport.com/device/K102643
Methodology: https://510kreport.com/methodology