Not Cleared Direct

DEN200044 - Eonis SCID-SMA Kit (FDA 510(k) Clearance)

Class II Medical Genetics device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN200044 · Perkinelmer, Inc. · Medical Genetics device
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Nov 2022
Decision
854d
Days
Class 2
Risk

DEN200044 is an FDA 510(k) submission (not cleared) for the Eonis SCID-SMA Kit. Classified as Spinal Muscular Atrophy Newborn Screening Test System (product code QUE), Class II - Special Controls.

Submitted by Perkinelmer, Inc. (Waltham, US). The FDA issued a Not Cleared (DENG) decision on November 9, 2022 after a review of 854 days.

This device falls under the Medical Genetics FDA review panel, regulated under 21 CFR 866.5980 - the FDA medical genetics device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 854 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Perkinelmer, Inc. devices

Submission Details

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 -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
455d slower than avg
Panel avg: 399d · This submission: 854d
Pathway characteristics

Device Classification

Product Code QUE Spinal Muscular Atrophy Newborn Screening Test System
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Medical Genetics devices follow this clearance model.