De Novo · Neurology

Cognoa ASD Diagnosis Aid

by Cognoa, Inc.

Cognoa ASD Diagnosis Aid is an AI-enabled medical device from Cognoa, Inc. that the U.S. FDA granted through De Novo DEN200069 on June 2, 2021. Its lead review panel is Neurology and its primary product code is QPF (Pediatric Autism Spectrum Disorder Diagnosis Aid).

See also all FDA AI clearances in 2021, top neurology AI devices.

Key facts

Submission numberDEN200069
PathwayDe Novo
Date of final decision
Company (FDA list)Cognoa, Inc.
Lead review panelNeurology
Primary product codeQPF — Pediatric Autism Spectrum Disorder Diagnosis Aid
Applicant (openFDA)Cognoa, Inc.
Applicant locationPalo Alto, CA, US
Device classClass 2
Regulation number21 CFR 882.1491
Decision codeDENG
Submission typeDirect

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

De Novo is the pathway for novel low-to-moderate-risk devices with no predicate. A granted De Novo creates a new device classification that later devices can use as a predicate. Cognoa ASD Diagnosis Aid went through this pathway (DEN200069).

openFDA lists it as a Class 2 device under 21 CFR 882.1491. Class II devices are moderate risk and are subject to general and special controls.

Product code QPF covers 6 devices on the FDA AI list. By decision date, this device is #1 of 6 under that code. Cognoa, Inc. has 2 AI-enabled devices on the list, and the Neurology panel accounts for 73 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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