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510(k) Data Aggregation

    K Number
    K992312
    Device Name
    K-ASSAY CRP (2), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATOR B
    Manufacturer
    KAMIYA BIOMEDICAL CO.
    Date Cleared
    1999-09-13

    (66 days)

    Product Code
    DCK
    Regulation Number
    866.5270
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The K-ASSAY CRP (2) Assay is intended to be used for the quantitative determination of CRP in serum by latex particle enhanced immunoturbidimetric assay. Measurement of C-Reactive Protein aids in evaluation of the amount of injury to body tissues. The K-ASSAY CRP Multi-Calibrator A is intended to be used for the calibration of the K-ASSAY CRP (2) Assay. The K-ASSAY CRP Multi-Calibrator B is intended to be used for the calibration of the K-ASSAY CRP (2) Assay.

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter and an accompanying "Indications for Use Statement" for the K-ASSAY CRP (2) Assay and related calibrators. It explicitly states that the device is "substantially equivalent" to legally marketed predicate devices.

    However, the provided text does not contain any information about acceptance criteria, specific device performance data from a study, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details about the training set used for the device.

    The document grants market clearance based on a determination of substantial equivalence to existing devices, meaning it doesn't require the detailed performance data and study descriptions typically found in a new device's clinical validation report.

    Therefore, I cannot provide the requested table and study details based on the input text. The text focuses solely on regulatory approval and states the intended use of the device.

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