Cleared Traditional

K213882 - EarliPoint System (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence.

K213882 · Earlitec Diagnostics, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2022
Decision
177d
Days
Class 2
Risk

K213882 is an FDA 510(k) clearance for the EarliPoint System. Classified as Pediatric Autism Spectrum Disorder Diagnosis Aid (product code QPF), Class II - Special Controls.

Submitted by Earlitec Diagnostics, Inc. (Atlanta, US). The FDA issued a Cleared decision on June 8, 2022 after a review of 177 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1491 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Earlitec Diagnostics, Inc. devices

Submission Details

510(k) Number K213882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 148d · This submission: 177d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QPF Pediatric Autism Spectrum Disorder Diagnosis Aid
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Neurology devices follow this clearance model.

Regulatory Consultant

Libramedical, Inc.
Sew-Wah Tay

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT03469986 Completed Observational Industry-sponsored

A Multi-site Comparison of Social Visual Engagement to Clinical Diagnosis for Autism Spectrum Disorder

Prospective, Pivotal, Double-Blinded Within-subject Comparison of the Marcus Autism Center Investigational Device and Current Best Practice Clinical Diagnosis For Autism Spectrum Disorder in Pediatric Subjects 16-30 Months of Age

505
Patients (actual)
6
Sites
Condition studied Autism Spectrum Disorder
Eligibility All sexes · 16 Months+
Principal investigator Cheryl Klaiman, PhD
Sponsor EarliTec Diagnostics, Inc (industry)
Started 2018-04-07 → Primary completion 2019-05-31
Primary outcome
Presence of Autism Spectrum Disorder
Secondary outcome
Social disability index
Study completed - no results published. This trial concluded in 2019 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov