Not Cleared Direct

DEN200062 - Parsortix PC1 Device (FDA 510(k) Clearance)

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

DEN200062 · Angle Europe , Ltd. · Medical Genetics device
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May 2022
Decision
603d
Days
Class 2
Risk

DEN200062 is an FDA 510(k) submission (not cleared) for the Parsortix PC1 Device. Classified as Circulating Tumor Cell (ctc) Enrichment Device (product code QSA), Class II - Special Controls.

Submitted by Angle Europe , Ltd. (Guildford, GB). The FDA issued a Not Cleared (DENG) decision on May 24, 2022 after a review of 603 days.

This device falls under the Medical Genetics FDA review panel, regulated under 21 CFR 866.6110 - 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 603 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 DEN200062 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 28, 2020
Decision Date May 24, 2022
Days to Decision 603 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
204d slower than avg
Panel avg: 399d · This submission: 603d
Pathway characteristics

Device Classification

Product Code QSA Circulating Tumor Cell (ctc) Enrichment Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6110
Definition A Circulating Tumor Cell Enrichment Device Is An In Vitro Diagnostic Device Used To Enrich Circulating Tumor Cells From The Peripheral Blood Of Patients Diagnosed With Cancer For Subsequent In Vitro Diagnostic 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.