510(k) · Cleared

Cleared

NeoLSD MSMS Kit

K190266510(k) TraditionalCleared May 3, 201984-day reviewClass II21 CFR 862.1488

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Perkinelmer, Inc. · PQW Alpha-D-Galactosidase A (Gla) Newborn Screening Test System

Cleared on May 3, 2019 as substantially equivalent to K173829 (Wallac Oy, A Subsidiary of Perkinelmer, 2018) after an 84-day review. Its family tree reaches back 2 generations to 2017.

Decided: May 3, 2019
Review: 84 days
Class: Class II
Product code: PQW
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to DEN150035 (2017). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backDEN150035 SEEKER SystemBaebies, Inc. · 2017
1 generation backK173829 NeoLSD MSMS kitWallac Oy, A Subsidiary of Perkinelmer · 2018
This deviceK190266 NeoLSD MSMS KitPerkinelmer, Inc. · 2019

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	DEN150035	SEEKER System	Baebies, Inc.	2017	—
−1	K173829	NeoLSD MSMS kit	Wallac Oy, A Subsidiary of Perkinelmer	2018	—
0 (this device)	K190266	NeoLSD MSMS Kit	Perkinelmer, Inc.	2019	—

FIG. 1 — Lineage of K190266, 2017–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K173829	NeoLSD MSMS kit Summary page 4 …ng test system Classification: 75 Chemistry Product Code: PQW, PQT, PQU, PQV, QCL, QCM Predicate device: NeoLSD MSMS Kit (K173829) NeoLSD MSMS Kit with QSight I…	Wallac Oy, A Subsidiary of Perkinelmer	2018	—

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 2 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All PQW devices

PQW Alpha-D-Galactosidase A (Gla) Newborn Screening Test System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · PQW

1in 2019

2007high 1 (2017) · low 0 (2007)2026

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	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	1	—	0
2018	1	—	0
2019	1	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	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 Mucopolyaccharidosis Type I (MPS I) Disease.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K190266 · printed Nov 6, 2026

Cite this page

510(k) Report. “K190266: 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/K190266

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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