510(k) · Cleared
ClearedNeoLSD MSMS kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wallac Oy, A Subsidiary of Perkinelmer · PQW Alpha-D-Galactosidase A (Gla) Newborn Screening Test System
Cleared on Jul 18, 2018 as substantially equivalent to DEN150035 (Baebies, Inc., 2017) after a 212-day review. Its family tree reaches back 1 generation to 2017. 1 later device descends from it.
- Decided
- Jul 18, 2018
- Review
- 212 days
- Class
- Class II
- Product code
- PQW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN150035 (2017). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K190266NeoLSD MSMS KitPerkinelmer, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN150035 | SEEKER System | Baebies, Inc. | 2017 | — |
| 0 (this device) | K173829 | NeoLSD MSMS kit | Wallac Oy, A Subsidiary of Perkinelmer | 2018 | — |
| +1 | K190266 | NeoLSD MSMS Kit | Perkinelmer, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
Sources: FDA 510(k) 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
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN150035 | SEEKER SystemSummary page 4…try Product Code: PQW, PQT, PQU, PQV, QCL, QCM Predicate device: Baebies SEEKER 4‐Plex Assay (IDUA/GAA/GBA/GLA) (DEN150035) Confidential 1 Wallac Oy, a subsi… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190266 | NeoLSD MSMS Kit | 2019 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K190266 (Perkinelmer, Inc., 2019) has gone furthest, with 0 descendants 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. 2018, 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173829 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173829: NeoLSD MSMS kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173829
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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