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510(k) Data Aggregation

    K Number
    K031563
    Device Name
    BINDAZYME CLQ CIC EIA KIT
    Manufacturer
    THE BINDING SITE, LTD.
    Date Cleared
    2003-09-10

    (114 days)

    Product Code
    DAK
    Regulation Number
    866.5240
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BINDAZYME CLQ CIC EIA KIT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This assay is designed for the in-vitro measurement of circulating immune complexes (CIC) that bind Clq, measurement on on serum. It is intended for the determination of presence in names patients with various autoimmune and other CICrelated disease, and is used in conjunction with other clinical findings.

    Device Description

    Not Found

    AI/ML Overview

    This FDA document is a 510(k) clearance letter for the BINDAZYME C1q Binding Circulating Immune Complex Enzyme Immunoassay Kit. It does not contain information about acceptance criteria or a study that proves the device meets those criteria.

    The letter confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It notes the "Indications for Use" but does not detail performance metrics, study designs, or ground truth establishment.

    Therefore, I cannot provide the requested information based on the provided text.

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