BEUDAMED
    Product Code: NIY FDA class 2 21 CFR 866.5660

    Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis

    Immunology

    The Anti-Soluble Liver Antigen (SLA) Autoantibodies test is an ELISA-based in vitro diagnostic device for the detection of anti-SLA antibodies of the IgG class in human serum, intended to aid in the diagnosis of autoimmune hepatitis and other conditions with elevated anti-SLA antibody levels. It is classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NIY and regulation 21 CFR 866.5660 in the Immunology specialty. The device is eligible for third-party review and carries no implant or life-sustaining flags.

    View on FDA
    510(k)s
    3
    FEI Numbers
    5
    Registration Numbers
    5
    Unique Applicants
    2
    Years Active
    11

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    Basic Information

    Product Code
    NIY
    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

    ELISA for the detection of anti-SLA (soluble liver antigen) antibody of the IgG class. Intended to aid in the diagnosis of conditions with elevated levels of anti-SLA antibody including autoimmune hepatitis

    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
    K113439 EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG)
    K112221 EUROIMMUN ANTI-SLA/LP ELISA(LGG)
    K021482 QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA

    FEI Numbers

    This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.