QUE

Spinal Muscular Atrophy Newborn Screening Test System

Product code

QUE

Device name

Spinal Muscular Atrophy Newborn Screening Test System

Device class

Class 2

21 CFR

21 CFR 866.5980

Medical specialty

Immunology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

A Spinal Muscular Atrophy (SMA) newborn screening test system is a prescription device intended to detect homozygous deletion of exon 7 or other similar mutations in the SMN1 (Survival Motor Neuron 1) gene of DNA obtained from dried blood spot specimens on filter paper using a polymerase chain reaction-based test as an aid in screening newborns for SMA. Presumptive positive results are intended to be followed up by diagnostic confirmatory testing.

Definition text from the FDA device classification database (U.S. federal government work, public domain).