FDA Product Code QPF: Pediatric Autism Spectrum Disorder Diagnosis Aid
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.
Leading manufacturers include Cognoa, Inc., Earlitec Diagnostics, Inc. and Earlitec Diagnostics.
7
Total
6
Cleared
170d
Avg days
2021
Since
Growing category -
4 submissions in the last 2 years
vs 1 in the prior period
Consistent review times:
166d avg (recent)
FDA 510(k) Cleared Pediatric Autism Spectrum Disorder Diagnosis Aid Devices (Product Code QPF)
7 devices
Cleared
Oct 02, 2026
Neurora
Argus Cognitive, Inc.
Neurology
266d
Cleared
Mar 05, 2026
EarliPoint Assessment
Earlitec Diagnostics
Neurology
155d
Cleared
Apr 11, 2025
Canvas Dx
Cognoa, Inc.
Neurology
144d
Cleared
Mar 26, 2025
EarliPoint System
Earlitec Diagnostics
Neurology
98d
Cleared
Jun 29, 2023
EarliPoint
Earlitec Diagnostics, Inc.
Neurology
142d
Cleared
Jun 08, 2022
EarliPoint System
Earlitec Diagnostics, Inc.
Neurology
177d
Not Cleared
Jun 02, 2021
Cognoa ASD Diagnosis Aid
Cognoa, Inc.
Neurology
211d
About Product Code QPF - Regulatory Context
510(k) Submission Activity
7 total 510(k) submissions under product code QPF since 2021, with 6 receiving FDA clearance (average review time: 170 days).
Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - QPF Product Code
FDA review times for QPF submissions have been consistent, averaging 166 days recently vs 177 days historically.
QPF devices are reviewed by the Neurology panel. Browse all Neurology devices →