Not Cleared Direct

DEN200069 - Cognoa ASD Diagnosis Aid (FDA 510(k) Clearance)

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

DEN200069 · Cognoa, Inc. · Neurology device
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Jun 2021
Decision
211d
Days
Class 2
Risk

DEN200069 is an FDA 510(k) submission (not cleared) for the Cognoa ASD Diagnosis Aid. Classified as Pediatric Autism Spectrum Disorder Diagnosis Aid (product code QPF), Class II - Special Controls.

Submitted by Cognoa, Inc. (Palo Alto, US). The FDA issued a Not Cleared (DENG) decision on June 2, 2021 after a review of 211 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1491 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Neurology review framework.

View all Cognoa, Inc. devices

Submission Details

510(k) Number DEN200069 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received November 03, 2020
Decision Date June 02, 2021
Days to Decision 211 days
Submission Type Direct
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 148d · This submission: 211d
Pathway characteristics

Device Classification

Product Code QPF Pediatric Autism Spectrum Disorder Diagnosis Aid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1491
Definition A Pediatric Autism Spectrum Disorder Diagnosis Aid Is A Prescription Device That Is Intended For Use As An Aid In The Diagnosis Of Autism Spectrum Disorder In Pediatric Patients.
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.