Spinal Muscular Atrophy Newborn Screening Test System
The Spinal Muscular Atrophy Newborn Screening Test System is a prescription molecular diagnostic device intended to detect homozygous deletion of exon 7 or similar mutations in the SMN1 gene from dried blood spot specimens on filter paper, using a PCR-based method to screen newborns for spinal muscular atrophy (SMA). Early detection enables timely initiation of disease-modifying therapies before symptom onset. Classified as FDA Class 2 under regulation 866.5980, it requires 510(k) clearance in the Immunology specialty, with review under the Medical Genetics panel. Presumptive positive results require confirmatory diagnostic testing, and the device is not an implant or life-sustaining.
Basic Information
- Product Code
- QUE
- Device Class
- FDA class 2
- Regulation Number
- 866.5980
- Medical Specialty
- Immunology
- Review Panel
- MG
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN200044 | Eonis SCID-SMA Kit | Nov 09, 2022 | Unknown | Perkinelmer, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.