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    K Number
    K021688
    Device Name
    NICALERT
    Manufacturer
    NYMOX PHARMACEUTICAL CORPORATION
    Date Cleared
    2002-10-18

    (149 days)

    Product Code
    MRS
    Regulation Number
    862.3220
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NICALERT

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

    NicAlert™ is intended for in vitro diagnostic professional use for the semiquantitative determination of cotinine in urine for the purpose of determining if an individual has been exposed to tobacco products such as cigarettes, pipes, or chewing tobacco within the past 48 hours. The cutoff concentration for the NicAlert™ test is 100 ng/mL. Second hand smoke exposure (environmental tobacco smoke) may cause a positive result in a non-user of tobacco products. The NicAlert™ Positive and Negative Controls are intended for in vitro diagnostic use for the quality control of the NicAlert™ test.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a letter from the FDA regarding the clearance of the NicAlert™ device. It does not contain information about acceptance criteria or a study proving the device meets said criteria. Therefore, I cannot fulfill your request based on the given input.

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