Neurology · 510(k) · 2025
EarliPoint System
EarliTec Diagnostics. Cleared by FDA on 26 March 2025 under submission K243891, product code QPF (pediatric autism spectrum disorder diagnosis aid). What FDA's record says, in FDA's words.
Device record · K243891
- Device. EarliPoint SystemDEVICE
- Company. EarliTec DiagnosticsCOMPANY
- Decision. 26 March 2025, 510(k), substantially equivalent (special review); received 18 December 2024DECISION
- 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 device is indicated as a tool to aid qualified clinicians in the diagnosis and assessment of Autism Spectrum Disorder (ASD) in children ages 16 months through 30 months, who are at risk based on concerns identified by a parent, caregiver, or healthcare provider. EarliPoint System Nonclinical and Clinical Data (unchanged from predicate device)
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.
- Mentionsa diagnostic claim
- Mentionspediatric patients
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, or cleared in 2025. 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.