EarliPoint System
by Earlitec Diagnostics, Inc. 510(k)
Active
510(k) K213882
Overview
The EarliPoint System is a diagnostic aid classified as a Pediatric Autism Spectrum Disorder Diagnosis Aid, designed to assist qualified clinicians in evaluating visual-attention patterns. It provides objective measurements to support the assessment of Autism Spectrum Disorder (ASD) in pediatric patients, complementing established diagnostic tools.
This system is intended for use in clinical settings by trained professionals and is supplied as a reusable device. It has received FDA clearance under a Traditional 510(k) pathway, with regulatory classification as a Class II device. No specific sterility or MRI safety information is provided in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK213882 | Date8 Jun 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- QPF
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.1491
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Earlitec Diagnostics
Questions
What clinical specialty is the EarliPoint System primarily intended for use within, and how does this relate to its design purpose?
The EarliPoint System is designed for use within the neurology specialty, as indicated by its regulatory classification and advisory committee designation. This aligns with its purpose as a diagnostic aid for evaluating visual-attention patterns in pediatric patients, which is a key component of assessing Autism Spectrum Disorder (ASD). Clinicians in neurology—particularly those specializing in developmental or behavioral pediatrics—would rely on this tool to complement existing diagnostic evaluations.
Is the EarliPoint System intended for single-use or reusable applications, and what does this mean for clinical workflows?
The EarliPoint System is explicitly described as a reusable device, meaning it is engineered for repeated use across multiple patients. This design choice supports clinical workflows by reducing waste and operational costs, though it also implies the need for proper cleaning, maintenance, and sterilization protocols (if applicable) between uses. Since no sterility information is provided, facilities must follow manufacturer guidelines to ensure safe reuse.
How does the EarliPoint System differ from traditional ASD diagnostic tools, and what role does it play in the diagnostic process?
Unlike traditional ASD diagnostic tools—which often rely on clinician observation, behavioral checklists, or parent interviews—the EarliPoint System provides objective measurements of visual-attention patterns to assist in evaluation. It serves as a complementary diagnostic aid, offering quantifiable data to support clinicians in assessing ASD symptoms in pediatric patients. While it does not replace established diagnostic criteria, it may help identify subtle patterns that could inform a more precise diagnosis.
What regulatory pathway was followed for FDA clearance of the EarliPoint System, and what does this imply about its safety and effectiveness?
The EarliPoint System received FDA clearance under a Traditional 510(k) pathway, classified as a Class II device, and was deemed *substantially equivalent* to a predicate device. This pathway indicates that the manufacturer demonstrated the device’s safety and performance through comparative analysis to an existing, legally marketed product. While clearance does not guarantee clinical efficacy, it confirms that the device meets FDA standards for its intended use as a diagnostic aid in ASD evaluation.