Not Cleared Direct

DEN130033 - COGNIVUE (FDA 510(k) Clearance)

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

DEN130033 · Cerebral Assessment Systems, Inc. · Neurology device
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Jun 2015
Decision
723d
Days
Class 2
Risk

DEN130033 is an FDA 510(k) submission (not cleared) for the COGNIVUE. Classified as Computerized Cognitive Assessment Aid (product code PKQ), Class II - Special Controls.

Submitted by Cerebral Assessment Systems, Inc. (Pittsford, US). The FDA issued a Not Cleared (DENG) decision on June 5, 2015 after a review of 723 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1470 - the FDA neurology 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 723 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 Cerebral Assessment Systems, Inc. devices

Submission Details

510(k) Number DEN130033 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received June 12, 2013
Decision Date June 05, 2015
Days to Decision 723 days
Submission Type Direct
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
575d slower than avg
Panel avg: 148d · This submission: 723d
Pathway characteristics

Device Classification

Product Code PKQ Computerized Cognitive Assessment Aid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1470
Definition The Computerized Cognitive Assessment Aid Provides Clinicians In A Healthcare Setting With Objective Measurements Of Cognitive Function As A Screening Aid In The Assessment Of Adults 55 Years Of Age And Older. This Is Done For The Purpose Of Identifying A Potential Decline In Cognitive Function Relative To Baseline Test Performance Of Other Age-normal Adults, Referring Those Adults For Further Testing Where Warranted, And Monitoring Changes In Cognitive Function Over Time
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 Neurology devices follow this clearance model.