Cleared Traditional

EarliPoint

K230337 · Earlitec Diagnostics, Inc. · Neurology
Jun 2023
Decision
142d
Days
Class 2
Risk

About This 510(k) Submission

K230337 is an FDA 510(k) clearance for the EarliPoint, a Pediatric Autism Spectrum Disorder Diagnosis Aid (Class II — Special Controls, product code QPF), submitted by Earlitec Diagnostics, Inc. (Atlanta, US). The FDA issued a Cleared decision on June 29, 2023, 142 days after receiving the submission on February 7, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1491.

Submission Details

510(k) Number K230337 FDA.gov
FDA Decision Cleared SESE
Date Received February 07, 2023
Decision Date June 29, 2023
Days to Decision 142 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.