Neurology · 510(k) · 2023
EarliPoint
EarliTec Diagnostics, Inc. Cleared by FDA on 29 June 2023 under submission K230337, product code QPF (pediatric autism spectrum disorder diagnosis aid). What FDA's record says, in FDA's words.
Device record · K230337
- Device. EarliPointDEVICE
- Company. EarliTec Diagnostics, IncCOMPANY
- Decision. 29 June 2023, 510(k), substantially equivalent (traditional review); received 7 February 2023DECISION
- Panel. NeurologyPANEL
- Product code. QPF, Pediatric Autism Spectrum Disorder Diagnosis AidCODE
- Regulation. 21 CFR 882.1491, Class IIREG
- Source. FDA database entry · decision document (8 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The EarliPoint System is indicated for use in specialized developmental disabilities centers as a tool to aid clinicians in the diagnosis and assessment of ASD patients ages 16 months through 30 months. 5 PREDICATE DEVICE The predicate device is the EarliPoint System cleared under 510(k) K213882. Both devices have the same intended use as an aid to diagnose and assess the presence of autism spectrum disorders (ASD) using a proprietary algorithm based on the looking behavior of the patient. 6 DEVICE DESCRIPTION The device is a more compact version of the predicate device but otherwise has similar functions and features. The system uses an eye tracker to capture the patient’s looking behavior while viewing a series of videos. The system then remotely analyzes the looking behavior data using software and outputs a diagnosis of the patient’s ASD status and assesses the symptoms associated with ASD. The system has two modules: EarliPoint System consists of the following: - Eye-tracking module and a separate Operator Module that can control the Eye-tracking module remotely. The patient sits on a chair and the Eye-tracking module is adjusted by the operator such that the patient’s eyes are within the specification of the eye tracking window - Eye-tracking module captures the patient visual response to social information provided in the form of a series of age-appropriate videos - Operator’s module is used to initiate and monitors the session remotely - WebPortal securely stores […]
The product code's definition, from FDA's classification record. 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 the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QPF. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QPF, in Neurology, from EarliTec Diagnostics, Inc, or cleared in 2023. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.