De Novo · Granted
GrantedSEEKER System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baebies, Inc. · PQW Alpha-D-Galactosidase A (Gla) Newborn Screening Test System
Granted on Feb 3, 2017 as a new device type through De Novo after a 548-day review. 2 later devices descend from it.
- Decided
- Feb 3, 2017
- Review
- 548 days
- Class
- Class II
- Product code
- PQW
- Recalls
- None
2 later devices descend from it, 1 citing it directly.
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN150035 | SEEKER System | Baebies, Inc. | 2017 | — |
| +1 | K173829 | NeoLSD MSMS kit | Wallac Oy, A Subsidiary of Perkinelmer | 2018 | — |
| +2 | K190266 | NeoLSD MSMS Kit | Perkinelmer, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PQW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173829 | NeoLSD MSMS kit | 2018 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K173829 (Wallac Oy, A Subsidiary of Perkinelmer, 2018) has gone furthest, with 1 descendant of its own.
How does its category compare?
All PQW devicesPQW Alpha-D-Galactosidase A (Gla) Newborn Screening Test System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PQW
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · PQW
Too few PQW 510(k)s in any year since 2007 to give a median.
Recalls per year · PQW
No recall names PQW since 2007.
Adverse event reports per year · PQW
No MAUDE report names PQW since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (109 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN150035 · printed Nov 4, 2026
Cite this page
510(k) Report. “DEN150035: SEEKER System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/DEN150035
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026