Neurology · 510(k) · 2022
EarliPoint System
EarliTec Diagnostics, Inc.. Cleared by FDA on 8 June 2022 under submission K213882, product code QPF (pediatric autism spectrum disorder diagnosis aid). What FDA's record says, in FDA's words.
Device record · K213882
- Device. EarliPoint SystemDEVICE
- Company. EarliTec Diagnostics, Inc.COMPANY
- Decision. 8 June 2022, 510(k), substantially equivalent (traditional review); received 13 December 2021DECISION
- Panel. NeurologyPANEL
- Product code. QPF, Pediatric Autism Spectrum Disorder Diagnosis AidCODE
- Regulation. 21 CFR 882.1491, Class IIREG
- Source. FDA database entry · decision document (10 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. 6 PERFORMANCE DATA The following performance data were provided in support of the substantial equivalence determination.
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 2022. 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.