QUE · Class II · 21 CFR 866.5980

FDA Product Code QUE: Spinal Muscular Atrophy Newborn Screening Test System

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.

Leading manufacturers include Perkinelmer, Inc..

1
Total
0
Cleared
854d
Avg days
2022
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Spinal Muscular Atrophy Newborn Screening Test System Devices (Product Code QUE)

1 devices
1–1 of 1
Not Cleared Nov 09, 2022
Eonis SCID-SMA Kit
DEN200044
Perkinelmer, Inc.
Medical Genetics · 854d

About Product Code QUE - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QUE since 2022, with 0 receiving FDA clearance (average review time: 854 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

QUE devices are reviewed by the Medical Genetics panel. Browse all Medical Genetics devices →