FDA product code · Clinical chemistry

Acid-Sphingomyelinase (Asm) Newborn Screening Test System

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

QCLClass II21 CFR 862.1488510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

For quantitative measurement of the activity of acid-sphingomyelinase (ASM) from newborn dried blood spot specimens as an aid in screening newborns for Niemann-Pick 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 QCL 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 — QCL by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QCL? 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…PQW Alpha-D-Galactosidase A (Gla) Newborn…PQU Alpha-D-Glucosidase (Gaa) Newborn Screening…QCM ß-Galactocerebrosidase (Galc) Newborn…