Cleared Traditional

EarliPoint System

K213882 · Earlitec Diagnostics, Inc. · Neurology
Jun 2022
Decision
177d
Days
Class 2
Risk

About This 510(k) Submission

K213882 is an FDA 510(k) clearance for the EarliPoint System, 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 8, 2022, 177 days after receiving the submission on December 13, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1491.

Submission Details

510(k) Number K213882 FDA.gov
FDA Decision Cleared SESE
Date Received December 13, 2021
Decision Date June 08, 2022
Days to Decision 177 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.