• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
New Search Back to Search Results
Device pediatric autism spectrum disorder diagnosis aid
Regulation Description Pediatric Autism Spectrum Disorder diagnosis aid.
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.
Physical State The device collects data based on the clinical presentation of a patient. An analysis algorithm is applied to the collected data. The device may be stand-alone or implemented as a software application on a smartphone or other general purpose computing platform.
Technical Method Performs an analysis of patient behavioral data to aid in the diagnosis of Autism Spectrum Disorder.
Target Area The device is intended to aid in the diagnosis of Autism Spectrum Disorder.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeQPF
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type 510(k)
Regulation Number 882.1491
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible