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    K Number
    K091486
    Device Name
    K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR
    Manufacturer
    KAMIYA BIOMEDICAL CO.
    Date Cleared
    2010-04-29

    (345 days)

    Product Code
    DCF,JIT
    Regulation Number
    866.5040
    Type
    Traditional
    Panel
    Clinical Chemistry (CH)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR

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

    The K-ASSAY® Microalbumin reagent is for the quantitative determination of human albumin in urine by immunoturbidimetric assay. Measurement of albumin in urine nids in the diagnosis of kidney dysfunction. FOR IN VITRO DIAGNOSTIC USE.

    K-ASSAY ® The Microalbumin Calibrator is for the calibration of the K-ASSAY® Microalbumin assay for quantifying albumin in urine speiment. FOR IN VITRO DIAGNOSTIC USE.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification approval letter from the FDA for a medical device called "K-Assay® Microalbumin" and "K-Assay® Microalbumin Calibrator". This type of document typically confirms that a new device is "substantially equivalent" to an already legally marketed device, but it does not specify acceptance criteria or detailed study results.

    Therefore, the requested information about acceptance criteria and the study proving the device meets them cannot be extracted from the provided text. The document primarily focuses on regulatory approval and classification rather than performance metrics.

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