510(k) DEN200044
DEN200044 is an FDA 510(k) premarket notification submitted by Perkinelmer, Inc. for the device "Eonis SCID-SMA Kit". The FDA issued a decision of De Novo Granted on November 9, 2022. The device falls under product code QUE (Spinal Muscular Atrophy Newborn Screening Test System), a Class II device regulated under 21 CFR 866.5980. Perkinelmer, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- November 9, 2022
- Date Received
- July 8, 2020
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spinal Muscular Atrophy Newborn Screening Test System
- Device Class
- Class II
- Regulation Number
- 866.5980
- Review Panel
- MG
- Submission Type
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.