Not Cleared Direct

DEN200080 - Paige Prostate (FDA 510(k) Clearance)

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

DEN200080 · Paige.Ai · Pathology device
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Sep 2021
Decision
264d
Days
Class 2
Risk

DEN200080 is an FDA 510(k) submission (not cleared) for the Paige Prostate. Classified as Software Algorithm Device To Assist Users In Digital Pathology (product code QPN), Class II - Special Controls.

Submitted by Paige.Ai (New York, US). The FDA issued a Not Cleared (DENG) decision on September 21, 2021 after a review of 264 days.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.3750 - the FDA pathology 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. Elevated predicate reliance profile. With 264 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 DEN200080 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 31, 2020
Decision Date September 21, 2021
Days to Decision 264 days
Submission Type Direct
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
187d slower than avg
Panel avg: 77d · This submission: 264d
Pathway characteristics

Device Classification

Product Code QPN Software Algorithm Device To Assist Users In Digital Pathology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.3750
Definition A Software Algorithm Device To Assist Users In Digital Pathology Is An In Vitro Diagnostic Device Intended To Evaluate Acquired Scanned Pathology Whole Slide Images. The Device Uses Software Algorithms To Provide Information To The User About Presence, Location, And Characteristics Of Areas Of The Image With Clinical Implications. Information From This Device Is Intended To Assist The User In Determining A Pathology Diagnosis.
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 Pathology devices follow this clearance model.