Cleared Traditional

K253442 - EarliPoint Assessment (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K253442 · Earlitec Diagnostics · Neurology device
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Optimized for regulatory review, auditing and printing
Mar 2026
Decision
155d
Days
Class 2
Risk

K253442 is an FDA 510(k) clearance for the EarliPoint Assessment. Classified as Pediatric Autism Spectrum Disorder Diagnosis Aid (product code QPF), Class II - Special Controls.

Submitted by Earlitec Diagnostics (Plymouth, US). The FDA issued a Cleared decision on March 5, 2026 after a review of 155 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.

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Submission Details

510(k) Number K253442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 148d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Consultant

RQM+
Amy Wolbeck

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.