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FDA PRODUCT CODE · CLASS II

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 882.1491
MEDICAL SPECIALTY
Neurology
REVIEW PANEL
NE
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
3
510(K)/PMA CLEARANCES
510k: 3
0
RECALL ENTRIES

Recent clearances

K253442Earlitec Diagnostics · 510k2026-03-05
K243558Cognoa, Inc. · 510k2025-04-11
K243891Earlitec Diagnostics · 510k2025-03-26

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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