BEUDAMED
    Product Code: PCN FDA class 2 21 CFR 866.5510

    Immunoglobulin G Kappa Heavy And Light Chain Combined

    Immunology

    The Immunoglobulin G Kappa Heavy and Light Chain Combined assay is an immunology in vitro diagnostic device intended for the in vitro quantification of IgG kappa concentration in human serum. It falls under the Immunology medical specialty and is classified as a Class 2 device under regulation 866.5510, requiring 510(k) premarket notification. Such assays are used in the diagnosis and monitoring of plasma cell disorders such as multiple myeloma and other monoclonal gammopathies. It is not an implant and is not life-sustaining.

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    510(k)s
    3
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    2
    Years Active
    4

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    Basic Information

    Product Code
    PCN
    Device Class
    FDA class 2
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Review Panel
    IM
    Submission Type
    1

    Device Characteristics

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

    Definition

    Intended for the in-vitro quantification of IgG kappa concentration in human serum.

    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
    K172613 Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit
    K161854 Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS
    K132555 HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA 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.