DeviceClearance

Product code QPF— Neurology

EarliPoint System

Classification name
Pediatric Autism Spectrum Disorder Diagnosis Aid
Device class
Class 2
Regulation
21 CFR 882.1491
Advisory panel
Neurology
Total cleared
6
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code QPF under 21 CFR 882.1491, via openFDA

Market context for product code QPF

FDA has cleared 6 devices under product code QPF between 2021 and 2026, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QPF

Recent clearances under product code QPF

Data sourced from openFDA. This site is unofficial and independent of the FDA.