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510(k) Data Aggregation

    K Number
    K060371
    Device Name
    THE EMIT 2000 TACROLIMUS CALIBRATORS
    Manufacturer
    DADE BEHRING, INC.
    Date Cleared
    2006-03-09

    (24 days)

    Product Code
    JIT
    Regulation Number
    862.1150
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Emit® 2000 Tacrolimus Calibrators are intended for use as a reference in measuring tacrolimus in human whole blood using the Emit® 2000 Tacrolimus Assay.

    Device Description

    The Emit® 2000 Tacrolimus Calibrators are intended for use as a reference in measuring tacrolimus in human whole blood using the Emit® 2000 Tacrolimus Assay. The calibrators contain tacrolimus in preserved whole blood hemolysate. The calibrator kit consists of one vial of each calibrator level with target concentrations of 0, 2.5, 5, 10, 20, and 30 ng/mL of tacrolimus.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for the Emit® 2000 Tacrolimus Calibrators, focusing on establishing substantial equivalence to a predicate device. It describes the device, its intended use, and comparison to the predicate, but does not provide details of performance studies with specific acceptance criteria.

    Therefore, I cannot populate the requested table and information.

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