Spinal Muscular Atrophy Newborn Screening Test System
QUE is the FDA product code for Spinal Muscular Atrophy Newborn Screening Test System, a class II device type, regulated under 21 CFR 866.5980. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QUE
- Device name
- Spinal Muscular Atrophy Newborn Screening Test System
- FDA 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.
- Regulation
- 21 CFR 866.5980
- Device class
- Class II
- Review panel
- Immunology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code QUE
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2022 | 1 |
Applicants with the most clearances
Product code QUE| Applicant | Clearances |
|---|---|
| Revvity Health Sciences, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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