Not Cleared Direct

DEN200059 - POMC/PCSK1/LEPR CDx Panel (FDA 510(k) Clearance)

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

DEN200059 · Preventiongenetics, LLC · Chemistry device
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Jan 2022
Decision
490d
Days
Class 2
Risk

DEN200059 is an FDA 510(k) submission (not cleared) for the POMC/PCSK1/LEPR CDx Panel. Classified as Setmelanotide Eligibility Gene Variant Detection System (product code QRV), Class II - Special Controls.

Submitted by Preventiongenetics, LLC (Marshfield, US). The FDA issued a Not Cleared (DENG) decision on January 21, 2022 after a review of 490 days.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1164 - the FDA in vitro diagnostics and chemistry 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 490 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.

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Submission Details

510(k) Number DEN200059 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 18, 2020
Decision Date January 21, 2022
Days to Decision 490 days
Submission Type Direct
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
402d slower than avg
Panel avg: 88d · This submission: 490d
Pathway characteristics

Device Classification

Product Code QRV Setmelanotide Eligibility Gene Variant Detection System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1164
Definition A Setmelanotide Eligibility Gene Variant Detection System Is A Qualitative In Vitro Diagnostic Device Intended To Detect Germline Variants Within Genes Isolated From Human Specimens For The Purpose Of Identifying Patients With Obesity Who May Benefit From Treatment With Setmelanotide In Accordance With The Approved Therapeutic Product Labeling.
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 Chemistry devices follow this clearance model.