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510(k) Data Aggregation

    K Number
    K973692
    Device Name
    UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE
    Manufacturer
    UNITED BIOTECH, INC.
    Date Cleared
    1998-02-09

    (136 days)

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

    UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE

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

    The UBI MAGIWEL™ C-Reactive Protein(CRP) AD-401 is a solid phase enzyme-linked immunosorbent assay(ELISA). This test kit provides quantitative measurement of CRP level in human serum to aid in the evaluation of the amount of injury to body tissues. (for Professional use only)

    Device Description

    The UBI MAGIWEL™ C-Reactive Protein(CRP) AD-401 is a solid phase enzyme-linked immunosorbent assay(ELISA).

    AI/ML Overview

    This is a letter from the FDA regarding the 510(k) premarket notification for the UBI MAGIWEL™ C-Reactive Protein (CRP) Quantitative AD-401 device. The document states that the device is substantially equivalent to legally marketed predicate devices and can proceed to the market.

    However, the provided text does not contain any information regarding acceptance criteria, device performance results, sample sizes for testing or training, data provenance, expert qualifications, adjudication methods, details of comparative effectiveness studies (MRMC), standalone performance, or the specific type of ground truth used.

    Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is a regulatory approval letter, not a scientific study report.

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