Cleared Traditional

EarliPoint Assessment

K253442 · Earlitec Diagnostics · Neurology
Mar 2026
Decision
155d
Days
Class 2
Risk

About This 510(k) Submission

K253442 is an FDA 510(k) clearance for the EarliPoint Assessment, a Pediatric Autism Spectrum Disorder Diagnosis Aid (Class II — Special Controls, product code QPF), submitted by Earlitec Diagnostics (Plymouth, US). The FDA issued a Cleared decision on March 5, 2026, 155 days after receiving the submission on October 1, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1491.

Submission Details

510(k) Number K253442 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 2025
Decision Date March 05, 2026
Days to Decision 155 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code QPF — Pediatric Autism Spectrum Disorder Diagnosis Aid
Device Class Class II — 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.