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Pediatric Autism Spectrum Disorder Diagnosis Aid

Page Type
Product Code
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
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.1491
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QPF is linked to regulation 21CFR882.1491, which does not seem to exist yet. It may be pending at the moment.

Pediatric Autism Spectrum Disorder Diagnosis Aid

Page Type
Product Code
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
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.1491
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QPF is linked to regulation 21CFR882.1491, which does not seem to exist yet. It may be pending at the moment.