FDA product code QUE: Spinal Muscular Atrophy Newborn Screening Test System
QUE is the FDA product code for spinal muscular atrophy newborn screening test system. It is a Class II device, regulated under 21 CFR 866.5980 and reviewed by the Medical Genetics panel. Devices under QUE reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Spinal Muscular Atrophy Newborn Screening Test System |
| Device class | Class II |
| Regulation | 21 CFR 866.5980 |
| Review panel | MG — Medical Genetics |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
Recalls for QUE devices
openFDA lists no recalls for product code QUE.
Frequently asked questions
What is FDA product code QUE?
QUE is the FDA product code for spinal muscular atrophy newborn screening test system. It is a Class II device, regulated under 21 CFR 866.5980 and reviewed by the Medical Genetics panel.
What device class is QUE?
Class II, regulation 21 CFR 866.5980. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QUE
- Run a recall and safety report across every QUE manufacturer
- Watch product code QUE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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