Not Cleared Direct

DEN190023 - AmplideX Fragile X Dx & Carrier Screen Kit (FDA 510(k) Clearance)

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

DEN190023 · Asuragen, Inc. · Medical Genetics device
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Feb 2020
Decision
309d
Days
Class 2
Risk

DEN190023 is an FDA 510(k) submission (not cleared) for the AmplideX Fragile X Dx & Carrier Screen Kit. Classified as Inherited Nucleotide Repeat Disorder Dna Test (product code OYV), Class II - Special Controls.

Submitted by Asuragen, Inc. (Austin, US). The FDA issued a Not Cleared (DENG) decision on February 21, 2020 after a review of 309 days.

This device falls under the Medical Genetics FDA review panel, regulated under 21 CFR 866.5970 - 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 309 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 Asuragen, Inc. devices

Submission Details

510(k) Number DEN190023 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received April 18, 2019
Decision Date February 21, 2020
Days to Decision 309 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
90d faster than avg
Panel avg: 399d · This submission: 309d
Pathway characteristics

Device Classification

Product Code OYV Inherited Nucleotide Repeat Disorder Dna Test
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5970
Definition An Inherited Nucleotide Repeat Disorder Dna Test Is A Prescription In Vitro Diagnostic Test That Is Intended To Detect And Identify The Number Of Nucleotide Repeats In A Gene Using Genomic Dna Isolated From Post-natal Patient Specimens. It Is Solely Intended As An Aid For Carrier Testing And As An Aid For The Diagnosis Of Inherited Nucleotide Repeat-associated Disorders. Assay Results Are Solely Intended To Be Used In Conjunction With Other Clinical And Diagnostic Findings. These Tests Do Not Include Those Indicated For Use For Fetal Diagnostic Testing Or Newborn Screening.
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.