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510(k) Data Aggregation

    K Number
    K050644
    Device Name
    VANCOUVER BIOTECH HUMAN CARDIAC TROPONIN I IMMUNOASSAY TEST KIT
    Manufacturer
    VANCOUVER BIOTECH LTD.
    Date Cleared
    2005-08-17

    (156 days)

    Product Code
    MMI
    Regulation Number
    862.1215
    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 VBL Serum Troponin I ELISA Test is intended for the quantitative determination of cardiac Troponin I in human serum. Measurement of Troponin I values are useful in the evaluation of acute myocardial infarction (AMI).

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a diagnostic test kit for cardiac Troponin I. It does not contain the acceptance criteria or a study describing the device's performance against those criteria.

    Therefore, I cannot extract the requested information as it is not present in the provided document. The letter only confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed subject to general controls.

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