Not Cleared Direct

Helix Laboratory Platform (DEN190035) - FDA 510(k) Clearance

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

DEN190035 · Helix Opco, LLC · Medical Genetics device
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Dec 2020
Decision
509d
Days
Class 2
Risk

DEN190035 is an FDA 510(k) submission (not cleared) for the Helix Laboratory Platform. Classified as Whole Exome Sequencing Constituent Device (product code QNC), Class II - Special Controls.

Submitted by Helix Opco, LLC (Toronto, CA). The FDA issued a Not Cleared (DENG) decision on December 23, 2020 after a review of 509 days.

This device falls under the Medical Genetics FDA review panel, regulated under 21 CFR 866.6000 - 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 509 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 Helix Opco, LLC devices

Submission Details

510(k) Number DEN190035 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received August 02, 2019
Decision Date December 23, 2020
Days to Decision 509 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
110d slower than avg
Panel avg: 399d · This submission: 509d
Pathway characteristics

Device Classification

Product Code QNC Whole Exome Sequencing Constituent Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6000
Definition A Whole Exome Sequencing Constituent Device Is For Germline Whole Exome Sequencing Of Genomic Deoxyribonucleic Acid (dna) Isolated From Human Specimens. The Dna Sequence Generated By This Device Is Intended As Input For Clinical Germline Dna Assays That Have Fda Marketing Authorization And Are Intended For Use With This Device.
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.