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510(k) Data Aggregation

    K Number
    K062981
    Device Name
    I-CHROMA CRP TEST
    Manufacturer
    BODITECH DIAGNOSTICS, INC.
    Date Cleared
    2007-07-13

    (287 days)

    Product Code
    DCN
    Regulation Number
    866.5270
    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 i-CHROMA™ CRP test along with i-CHROMA™ Reader is an in vitro diagnostic fluorescence immunoassay that measures C-Reactive Protein in whole blood and serum. Measurement of C-Reactive Protein aids in evaluation of the amount of injury to body tissues, infection, and inflammatory disorders.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding the "i-Chroma CRP Test". This document approves the device based on its substantial equivalence to a predicate device. However, it does not contain specific details about acceptance criteria, a study proving the device meets those criteria, or the methodology of such a study.

    Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth types, training set size, or how its ground truth was established) from the provided text. The document is primarily an approval letter and does not delve into the technical details of the validation studies beyond stating that a review was conducted.

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