Not Cleared Direct

DEN210035 - “Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm” (FDA 510(k) Clearance)

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

DEN210035 · Hologic, Inc. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2024
Decision
887d
Days
Class 2
Risk

DEN210035 is an FDA 510(k) submission (not cleared) for the “Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm”. Classified as Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm (product code QYV), Class II - Special Controls.

Submitted by Hologic, Inc. (Malborough, US). The FDA issued a Not Cleared (DENG) decision on January 31, 2024 after a review of 887 days.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.3900 - 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. High predicate equivalence gap. With 887 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 Hologic, Inc. devices

Submission Details

510(k) Number DEN210035 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received August 27, 2021
Decision Date January 31, 2024
Days to Decision 887 days
Submission Type Direct
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
810d slower than avg
Panel avg: 77d · This submission: 887d
Pathway characteristics

Device Classification

Product Code QYV Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.3900
Definition The Digital Cervical Cytology Slide Imaging System With Artificial Intelligence (ai) Algorithm Is A Prescription In Vitro Diagnostic Device Consisting Of An Automated Digital Slide Creation, Viewing, And Management System Intended To Aid In The Review Of Digital Images Of Slides Prepared From Pap Test Specimens And Conventional Pap Smears By Selecting And Presenting Areas Of Interest To Facilitate Interpretation By The Reader. The Ai Software Algorithm Uses Machine Learning Techniques To Provide Information To The User About The Presence, Location, Or Characteristics Of Areas Of The Image With Clinical Implications. Information From This Device Is Intended To Assist The User In Rendering A Cytology 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.