# K990827: Microplate Neonatal Galt Assay

- Pathway: 510(k) (Special)
- Applicant: Bio-Rad
- Decided: Apr 9, 1999 after 28 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: 1 generation back to K961432 (1996). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961432: Radias Galt Test, Bio-Rad (1996) Summary page 1.

## Most influential descendants
- K102643: Spotcheck Neonatal Galt Microplate Reagent Kit (2011), 0 descendants of its own
- K090940: Spotcheck Blood Spot Control, Assayed (2009), 0 descendants of its own
- K993536: Bio-Rad Coda Neonatal Galt Assay (1999), 0 descendants of its own

## Indications for use
This assay is for the qualitative determination of galactose-1-phosphate uridyl transferase (GALT) activity in dried blood spot samples. Measurements of GALT are used in the diagnosis and treatment of the hereditary disease galactosemia (disorder of galactose metabolism) in infants. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K990827
Methodology: https://510kreport.com/methodology