BEUDAMED
    Product Code: QPF FDA class 2 21 CFR 882.1491

    Pediatric Autism Spectrum Disorder Diagnosis Aid

    Neurology

    The Pediatric Autism Spectrum Disorder Diagnosis Aid is a prescription neurological device intended for use as an aid in the diagnosis of Autism Spectrum Disorder in pediatric patients, leveraging software or sensor-based tools to support clinical assessment. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 882.1491 in the Neurology specialty. It carries product code QPF and is not an implant and not life-sustaining.

    View on FDA
    510(k)s
    6
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    3
    Years Active
    5

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    Basic Information

    Product Code
    QPF
    Device Class
    FDA class 2
    Regulation Number
    882.1491
    Medical Specialty
    Neurology
    Review Panel
    NE
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    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.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 6 510(k) clearances via K numbers.

    K Number Device Name
    K253442 EarliPoint Assessment
    K243558 Canvas Dx
    K243891 EarliPoint System
    K230337 EarliPoint
    K213882 EarliPoint System
    DEN200069 Cognoa ASD Diagnosis Aid

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.