# K993536: Bio-Rad Coda Neonatal Galt Assay

- Pathway: 510(k) (Special)
- Applicant: Bio-Rad
- Decided: Nov 4, 1999 after 16 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). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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). Our OCR of the scanned summary read K998027, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Microplate Neonatal GALT Assay”. Summary page 2.
- K961432: Radias Galt Test, Bio-Rad (1996) Summary page 1.

## Indications for use
This assay is for the qualitative determination of galactose-1-phosphate uridyl transferase activity in dried blood spot samples using the Bio-Rad CODA Analyzer. 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/K993536
Methodology: https://510kreport.com/methodology