QPF

Pediatric Autism Spectrum Disorder Diagnosis Aid

Product code
QPF
Device name
Pediatric Autism Spectrum Disorder Diagnosis Aid
Device class
Class 2
21 CFR
21 CFR 882.1491
Medical specialty
Neurology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
3
Summaries archived here
2 (direct download)
510(k) clearances (all years, FDA)
6 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2026-03-05.

NumberDecision dateApplicantDevice nameSummary
K2534422026-03-05Earlitec DiagnosticsEarliPoint AssessmentPDF
K2435582025-04-11Cognoa, Inc.Canvas DxPDF
K2438912025-03-26Earlitec DiagnosticsEarliPoint SystemFDA

2 summaries are archived here for direct download.

Official FDA classification page: QPF
Classification and pathway per current FDA publications. Data from openFDA (CC0).