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510(k) Data Aggregation

    K Number
    K991166
    Device Name
    K-ASSAY MICROALBUMIN CALIBRATOR SET
    Manufacturer
    KAMIYA BIOMEDICAL CO.
    Date Cleared
    1999-06-10

    (64 days)

    Product Code
    JIX
    Regulation Number
    862.1150
    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 K-ASSAY Microalbumin Calibrator Set is intended to be used for the calibration of the K-ASSAY Microalbumin immunoturbidimetric assay for quantitating albumin in urine specimens.

    Device Description

    Not Found

    AI/ML Overview

    There is no information in the provided document about acceptance criteria, device performance, sample size for test or training sets, ground truth establishment, or expert involvement. The document is primarily an FDA clearance letter for a medical device (K-ASSAY Microalbumin Calibrator Set) and an "Indications For Use Statement." It states that the device is "substantially equivalent" to legally marketed predicate devices, but it does not detail any specific performance studies or criteria beyond that regulatory determination.

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