BEUDAMED
    Product Code: JKM FDA class 2 21 CFR 866.5150

    Immunochemical, Bence-Jones Protein

    Immunology

    This device is an immunochemical test system used to detect Bence-Jones protein (free immunoglobulin light chains) in urine, a finding associated with plasma cell dyscrasias such as multiple myeloma and Waldenstrom macroglobulinemia, where abnormal light chains are filtered into the urine. It is classified as FDA Class 2 and requires 510(k) premarket notification, falling under the Immunology medical specialty, regulated under 21 CFR 866.5150. This device is eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    4
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    4
    Years Active
    10

    Basic Information

    Product Code
    JKM
    Device Class
    FDA class 2
    Regulation Number
    866.5150
    Medical Specialty
    Immunology
    Review Panel
    IM
    Submission Type
    1

    Device Characteristics

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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 4 510(k) clearances via K numbers.

    K Number Device Name
    K080916 CAPILLARYS URINE
    K070486 CAPILLARYS URINE (PN 2012)
    K050119 PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT
    K972591 HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.