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    K Number
    K021660
    Device Name
    K-ASSAY LP(A) ASSAY
    Manufacturer
    KAMIYA BIOMEDICAL CO.
    Date Cleared
    2002-07-25

    (66 days)

    Product Code
    DFC
    Regulation Number
    866.5600
    Type
    Traditional
    Panel
    Clinical Chemistry (CH)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    K-ASSAY LP(A) ASSAY

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

    The Kamiya K-ASSAY® Lp(a) Assay is an in vitro diagnostic reagent for the quantitative determination of human Lp(a) in human serum by immunoturbidimetric assay. The test may provide in conjunction with other lipoprotein tests, the risk assessment of coronary artery disease for specific populations.

    The K-ASSAY ® Lp(a) Calibrator Set is an in vitro diagnostic reagent for calibration of the K-ASSAY® Lp(a) Assay.

    For in vitro diagnostic use.

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for an in vitro diagnostic device, not a study report. Therefore, it does not contain the detailed information requested regarding acceptance criteria, device performance, study design, or ground truth establishment.

    The letter simply states that the FDA has reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This means it has met the regulatory requirements for clearance, not that a specific performance study with acceptance criteria has been detailed in this document.

    To provide the requested information, a separate study report or regulatory submission document detailing the performance evaluation of the K-Assay® Lipoprotein (a) Immunoturbidimetric Assay would be necessary.

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