# DEN150035: SEEKER System

- Pathway: De Novo (Direct)
- Applicant: Baebies, Inc.
- Decided: Feb 3, 2017 after 548 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
No predicates in its family tree.
2 later devices descend 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)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K173829: NeoLSD MSMS kit (2018), 1 descendant of its own
- K190266: NeoLSD MSMS Kit (2019), 0 descendants of its own

## Indications for use
The SEEKER System, including the SEEKER Instrument and the SEEKER LSD Reagent Kit - IDUA|GAA|GBA|GLA for use on the SEEKER Instrument, is intended for quantitative measurement of the activity of α-L-iduronidase, α-D-glucosidase, β-glucocerebrosidase and α-D-galactosidase A from newborn dried blood spot specimens as an aid in screening newborns for Mucopolysaccharidosis Type I, Pompe, Gaucher and Fabry diseases. Reduced activity of these enzymes may be indicative of these lysosomal storage diseases. The enzymes measured using the SEEKER LSD Reagent Kit- IDUA|GAA|GBA|GLA and their associated lysosomal storage diseases are listed below. Enzyme (abbreviation) Disease α-L-iduronidase (IDUA) Mucopolysaccharidosis Type I (MPS I) α-D-glucosidase (GAA) Pompe β-glucocerebrosidase (GBA) Gaucher α-D-galactosidase A (GLA) Fabry

Source page: https://510kreport.com/device/DEN150035
Methodology: https://510kreport.com/methodology