# K071649: Neonatal Total Galactose Kit; Neontal Total Galactose Kit, Models 3029-0010 and 3029-110B

- Pathway: 510(k) (Traditional)
- Applicant: Wallac OY
- Decided: Aug 7, 2008 after 416 days
- Product code: JIA (Enzymatic Methods, Galactose)
- Device class: 1
- Regulation: 21 CFR 862.1310
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K990654 (1999). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990654: Quantase Total Galactose Screening Assay 500 Test Kit, Quantase, Ltd. (1999) Summary page 1.

## Most influential descendants
- K133652: GSP Neonatal Total Galactose Kit (2014), 1 descendant of its own
- K190335: GSP Neonatal Total Galactose kit (2019), 0 descendants of its own

## Recalls of this device
- Nov 26, 2012 · Class II · Z-0688-2013: Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
- Nov 26, 2012 · Class II · Z-0689-2013: Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
- Nov 26, 2012 · Class II · Z-0690-2013: Truncated V-Bottomed Microplate Wells used in assays contain defective wells.

## Indications for use
This kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia.

Source page: https://510kreport.com/device/K071649
Methodology: https://510kreport.com/methodology