DeviceClearance

Product code QUE— Immunology

Eonis SCID-SMA Kit

Classification name
Spinal Muscular Atrophy Newborn Screening Test System
Device class
Class 2
Regulation
21 CFR 866.5980
Advisory panel
Immunology
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QUE under 21 CFR 866.5980, via openFDA

Market context for product code QUE

FDA has cleared 1 device under product code QUE, all in 2022, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QUE

Recent clearances under product code QUE

Data sourced from openFDA. This site is unofficial and independent of the FDA.