# K173829: NeoLSD MSMS kit

- Pathway: 510(k) (Traditional)
- Applicant: Wallac Oy, A Subsidiary of Perkinelmer
- Decided: Jul 18, 2018 after 212 days
- Product code: PQW (Alpha-D-Galactosidase A (Gla) Newborn Screening Test System)
- Device class: 2
- Regulation: 21 CFR 862.1488
- 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 DEN150035 (2017). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN150035: SEEKER System, Baebies, Inc. (2017) Summary page 4.

## Most influential descendants
- K190266: NeoLSD MSMS Kit (2019), 0 descendants of its own

## Indications for use
The NeoLSD MSMS Kit is intended for the quantitative measurement of the activity of the enzymes acid-β-glucocerebrosidase (ABG), acid-sphingomyelinase (ASM), acid-α-glucosidase (GAA), β-galactocerebrosidase (GALC), α-galactosidase A (GLA) and α-L-iduronidase (IDUA) in dried blood spots (DBS) from newborn babies. The analysis of the enzymatic activity is intended as an aid in screening newborns for the following lysosomal storage disorders (LSD) respectively; Gaucher Disease, Niemann-Pick A/B Disease, Pompe Disease, Krabbe Disease, Fabry Disease, and MPS I Disease.

Source page: https://510kreport.com/device/K173829
Methodology: https://510kreport.com/methodology