# K190266: NeoLSD MSMS Kit

- Pathway: 510(k) (Traditional)
- Applicant: Perkinelmer, Inc.
- Decided: May 3, 2019 after 84 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: 2 generations back to DEN150035 (2017). 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)
- K173829: NeoLSD MSMS kit, Wallac Oy, A Subsidiary of Perkinelmer (2018) Summary page 4.

## 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 Mucopolyaccharidosis Type I (MPS I) Disease.

Source page: https://510kreport.com/device/K190266
Methodology: https://510kreport.com/methodology