510(k) Report

FDA product code · Clinical chemistry

Alpha-D-Galactosidase A (Gla) Newborn Screening Test System

PQWClass II21 CFR 862.1488510(k) required3 decisions since 20170 recalls

3 FDA decisions since 2017. No recall names this code. The most-cited predicate is DEN150035, named by 1 later device.

For quantitative measurement of the activity of alpha-D-galactosidase A (GLA) from newborn dried blood spot specimens.

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

FIG. A — Illustration, clinical chemistry panel

Twenty years of PQW at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · PQW

1in 2019

2017: 12018: 12019: 1
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20171—00
20181—00
20191—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — PQW by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PQW? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do PQW devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • DEN150035SEEKER SystemBaebies, Inc. · 20171cites it
  • K173829NeoLSD MSMS kitWallac Oy, A Subsidiary of Perkinelmer · 20181cites it

Which PQW devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K190266NeoLSD MSMS KitPerkinelmer, Inc. · 20192generations
  • K173829NeoLSD MSMS kitWallac Oy, A Subsidiary of Perkinelmer · 20181generation

What has FDA decided in PQW lately?

  • K190266NeoLSD MSMS KitPerkinelmer, Inc. · 2019
  • K173829NeoLSD MSMS kitWallac Oy, A Subsidiary of Perkinelmer · 2018
  • DEN150035SEEKER SystemBaebies, Inc. · 2017

All 3 PQW decisions →

Related product codes

Other codes under 21 CFR 862.1488.

PQV ß-Glucocerebrosidase (Gba) Newborn Screening…PQT Alpha-L-Iduronidase (Idua) Newborn Screening…QCL Acid-Sphingomyelinase (Asm) Newborn Screening…PQU Alpha-D-Glucosidase (Gaa) Newborn Screening…QCM ß-Galactocerebrosidase (Galc) Newborn…