Spinal Muscular Atrophy Newborn Screening Test System
QUE · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5980
Classification
FDA Product Code
QUE
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.5980
Review panel
MG
Medical specialty
Immunology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.