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510(k) Data Aggregation

    K Number
    K014084
    Device Name
    NYCOCARD CRP CONTROL
    Manufacturer
    PRIMUS CORP.
    Date Cleared
    2002-01-07

    (27 days)

    Product Code
    DCK
    Regulation Number
    866.5270
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    K013787
    Why did this record match?
    Device Name :

    NYCOCARD CRP CONTROL

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

    The NycoCard® CRP Control is an assayed human serum control material intended to monitor and evaluate the precision and accuracy of quantitative C-reactive protein (CRP) assays. It is particularly recommended for use with the NycoCard® CRP point-ofcare test system for determination of C-reactive protein (510(k) submission date November 13. 2001, (K013787, Establishment Registration Number 1931251). Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissue.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding the "NycoCard® CRP Control" device. It is a control material used to monitor the precision and accuracy of C-reactive protein (CRP) assays, particularly with the NycoCard® CRP point-of-care test system.

    The document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory approval letter based on substantial equivalence to a predicate device, not a performance study report.

    Therefore, I cannot provide the requested information.

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