BEUDAMED
    Product Code: OIF FDA class 2 21 CFR 866.5660

    Tyrosine Phosphatase (Ia-2) Autoantibody Assay

    Immunology

    The Tyrosine Phosphatase (IA-2) Autoantibody Assay is an in vitro diagnostic device used for the semi-quantitative detection of autoantibodies against the islet antigen tyrosine phosphatase IA-2 in human serum, serving as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune-mediated diabetes). Classified as FDA Class 2 under regulation 21 CFR 866.5660 within the Immunology medical specialty, it requires a 510(k) premarket notification and is eligible for third-party review. The product code is OIF. It is not flagged as an implant or life-sustaining device.

    View on FDA
    510(k)s
    3
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    2
    Years Active
    15

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    Basic Information

    Product Code
    OIF
    Device Class
    FDA class 2
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Review Panel
    IM
    Submission Type
    1

    Device Characteristics

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

    Definition

    The device is used for the semi-quantitative determination of autoantibodies against tyrosine phosphatase (IA-2) in human serum as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes).

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 3 510(k) clearances via K numbers.

    K Number Device Name
    K220085 KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit
    K171731 KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit
    K073590 KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT

    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.