QCLClass II

Acid-Sphingomyelinase (Asm) Newborn Screening Test System

21 CFR 862.1488 / Clinical Chemistry

QCL is the FDA product code for Acid-Sphingomyelinase (Asm) Newborn Screening Test System, a class II device type, regulated under 21 CFR 862.1488. FDA's definition for this code reads: "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". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: QCL
Device name: Acid-Sphingomyelinase (Asm) Newborn Screening Test System
FDA definition: 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.
Regulation: 21 CFR 862.1488
Device class: Class II
Review panel: Clinical Chemistry
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

Wallac Oy

Recent clearances

Product code QCL

FDA records hold no clearances under product code QCL.

Recent recalls

Product code QCL

FDA records show no recalls under product code QCL.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)