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510(k) Data Aggregation

    K Number
    K014270
    Device Name
    MININEPH HUMAN B2-MICROGLOBULIN KIT
    Manufacturer
    THE BINDING SITE, LTD.
    Date Cleared
    2002-08-15

    (231 days)

    Product Code
    JZG,JZW
    Regulation Number
    866.5630
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This kit is designed for the in vitro measurement of human B2-Microglobulin in serum and urine using the Minineph, to aid in the diagnosis of active rheumatoid arthritis and kidney disease.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the requested format. The document is an FDA 510(k) clearance letter for the "MININEPH® Human Beta-2 Microglobulin Kit," which primarily outlines the regulatory approval based on substantial equivalence to a predicate device.

    It does not include details about:

    • A table of acceptance criteria and reported device performance.
    • Sample sizes for test sets or data provenance.
    • Information on experts for ground truth establishment.
    • Adjudication methods.
    • Multi-reader multi-case (MRMC) comparative effectiveness studies.
    • Standalone algorithm performance.
    • Type of ground truth used.
    • Sample size for the training set.
    • How ground truth for the training set was established.

    The document only states the device's indications for use: "to aid in the diagnosis of active rheumatoid arthritis and kidney disease" by measuring human B2-Microglobulin in serum and urine.

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