FDA product code · Clinical chemistry

ß-Galactocerebrosidase (Galc) Newborn Screening Test System

Name: FDA decisions, review times, recalls and adverse event reports for product code QCM
Creator: 510(k) Report

QCMClass II21 CFR 862.1488510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

For quantitative measurement of the activity of ß-galactocerebrosidase (GALC) from newborn dried blood spot specimens as an aid in screening newborns for Krabbe disease.

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 QCM 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.

FIG. 1 — QCM by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QCM? 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

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…PQW Alpha-D-Galactosidase A (Gla) Newborn…PQU Alpha-D-Glucosidase (Gaa) Newborn Screening…