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NeoLSD MSMS Kit

by Wallac Oy, A Subsidiary of Perkinelmer

510(k) K173829

Active European Union and United States

CE IVDR CE IVDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K173829↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK173829 Date18 Jul 2018ClearedStatusActive
European UnionCE/IVDR EUDAMED Number— Date—StatusActive
European UnionCE/IVDD EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR, CE/IVDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
PQW
Device Class
Class II
Regulation
21 CFR Part 862.1488
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The NeoLSD MSMS Kit is a Newborn Screening Test System for Alpha-D-Galactosidase A (Gla), classified under the FDA’s Alpha-D-Galactosidase A (Gla) Newborn Screening Test System nomenclature. It is designed to detect and measure Alpha-D-Galactosidase A enzyme activity in dried blood spots from newborns, aiding in the early identification of Fabry disease.

This kit is supplied as a traditional 510(k) cleared diagnostic device under the FDA’s Clinical Chemistry advisory committee, with FDA 510(k) clearance (K173829) and IVDR compliance. It is intended for single-use in clinical chemistry laboratories and requires adherence to standard newborn screening protocols. Storage and handling follow manufacturer guidelines to maintain assay integrity.

Other devices from Wallac Oy, A Subsidiary of Perkinelmer, Inc.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the NeoLSD MSMS kit used for in newborn screening programs?

    The NeoLSD MSMS kit is designed to detect and measure Alpha-D-Galactosidase A (Gla) enzyme activity in dried blood spots from newborns. This helps identify early signs of Fabry disease, a rare genetic disorder, enabling timely clinical intervention.

  • Is the NeoLSD MSMS kit intended for single-use or repeated use in a clinical setting?

    The NeoLSD MSMS kit is explicitly intended for single-use in clinical chemistry laboratories. This aligns with standard newborn screening protocols and ensures assay integrity, as reuse could compromise accuracy or sterility.

  • How should the NeoLSD MSMS kit be stored to maintain its performance?

    The kit must be stored and handled according to the manufacturer’s guidelines to preserve assay integrity. While specific storage conditions (e.g., temperature, humidity) aren’t detailed here, adherence to these instructions is critical for reliable test results in newborn screening programs.

  • What regulatory pathways does the NeoLSD MSMS kit follow, and where is it cleared or authorized?

    The NeoLSD MSMS kit holds FDA 510(k) clearance (K173829) under the Clinical Chemistry advisory committee, classifying it as a substantially equivalent diagnostic device. It also complies with the In Vitro Diagnostic Regulation (IVDR) in the EU, ensuring its use aligns with both U.S. and European regulatory standards for newborn screening.