Devices · EarliTec Diagnostics

EarliPoint System

EarliTec Diagnostics is listed for EarliPoint System (K243891). The FDA list gives March 26, 2025 as the date of the final decision. The lead panel is Neurology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code QPF as “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. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243891

Official FDA database record

Date of final decision

March 26, 2025

Company on the FDA list

EarliTec Diagnostics

Lead panel

Neurology

Primary product code

QPF

openFDA device name for the code

Pediatric Autism Spectrum Disorder Diagnosis Aid

Device class

2

Regulation number

882.1491

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary