EarliPoint

Basic Information

• Brand Name: EarliPoint
• Primary DI: 00860009993709
• Version / Model: EPT001
• Company Name: Earlitec Diagnostics, Inc.
• Labeler DUNS: 117950776
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-26
• Public Version: 1
• Public Version Date: 2023-08-03
• Public Version Status: New
• Public Device Record Key: 473c75fd-0e52-4c1e-b98f-499708e06231

Device Description

The EarliPoint System is an eye tracking device used as a tool to aid clinicians in the diagnosis and assessment of ASD patients.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QPF	Pediatric Autism Spectrum Disorder Diagnosis Aid	Neurology	882.1491	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65894	Neurodevelopmental disorder interpretive software	An interpretive, machine-learning-enabled software as a medical device (SaMD) application intended to be used to aid a healthcare professional in the diagnosis of a neurodevelopmental disorder (e.g., autism). It analyses patient demographics and questionnaire data from one or more sources (e.g., parent/caregiver, healthcare professionals) and provides an assessment. It is designed to be installed on an off-the-shelf device and intended primarily for use by a healthcare professional, however includes a parent/caregiver facing application.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860009993709	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K230337	000