DEN200044 is an FDA 510(k) submission for the Eonis SCID-SMA Kit. This device is classified as a Spinal Muscular Atrophy Newborn Screening Test System (Class II - Special Controls, product code QUE).
Submitted by Perkinelmer, Inc. (Waltham, US). The FDA issued a Not Cleared (DENG) decision on November 9, 2022.
This device falls under the Medical Genetics FDA review panel. Regulated under 21 CFR 866.5980. 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) Number | DEN200044 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | July 08, 2020 |
| Decision Date | November 09, 2022 |
| Days to Decision | 854 days |
| Submission Type | Direct |
| Review Panel | Medical Genetics (MG) |
| Summary | - |
| Product Code | QUE - Spinal Muscular Atrophy Newborn Screening Test System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5980 |
| 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. |