| 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 Code | QPF |
|---|
| 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
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
