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. and Revvity, Inc..
2
Total
1
Cleared
449d
Avg days
2022
Since
Stable submission activity - 1 submissions in the last 2 years
Review times improving: avg
44d
recently vs 854d historically
FDA 510(k) Cleared Spinal Muscular Atrophy Newborn Screening Test System Devices (Product Code QUE)
2 devices
Cleared
Sep 30, 2026
Eonis™ SMA kit
Revvity, Inc.
Chemistry
44d
Not Cleared
Nov 09, 2022
Eonis SCID-SMA Kit
Perkinelmer, Inc.
Medical Genetics
854d
About Product Code QUE - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code QUE since 2022, with 1 receiving FDA clearance (average review time: 449 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA 510(k) Review Time - QUE Product Code
Recent submissions under QUE have taken an average of 44 days to reach a decision - down from 854 days historically, suggesting improved FDA processing for this classification.
QUE devices are reviewed by the Chemistry panel. Browse all Chemistry devices →