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    K Number
    K021194
    Device Name
    RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM
    Manufacturer
    HEMAGEN DIAGNOSTICS, INC.
    Date Cleared
    2002-07-29

    (105 days)

    Product Code
    DCK
    Regulation Number
    866.5270
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM

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

    Reagent: This reagent is intended for the quantitative in vitro measurements of C-reactive protein (CRP) in human serum or heparin and EDTA plasma. Measurement of C-reactive protein is useful in the detection and evaluation of infection, tissue injury and inflammatory disorders. Calibrator: The Raichem C-reactive Protein (CRP) Serum Calibrators are prepared from pooled human serum with added CRP purified from human pleural fluid, and are for use as calibrators in the measurement of CRP by latex turbidimetric immunoassays. Preservatives and stabilizers have been added.

    Device Description

    Not Found

    AI/ML Overview

    This an in-vitro diagnostic device, and the provided text does not contain the detailed study information typically associated with the acceptance criteria and performance evaluation of AI/ML-driven devices. The document is a 510(k) clearance letter for a C-reactive protein (CRP) test system, indicating it's a traditional medical device rather than an AI/ML product.

    Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence to a predicate device, rather than detailed performance studies against specific acceptance criteria using AI/ML methodologies.

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