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    K Number
    K102131
    Device Name
    NANO-CHECK AMI CTNI CARDIAC MARKER TEST
    Manufacturer
    NANO-DITECH CORPORATION
    Date Cleared
    2010-10-20

    (83 days)

    Product Code
    MMI
    Regulation Number
    862.1215
    Type
    Special
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The In Vitro Nano-Check ™ AMI cTnI Test is a rapid immunoassay for the qualitative determination of Cardiac Troponin I (cTnl) in human serum and plasma specimens at cutoff concentrations of 0.5 ng/ml respectively, as an aid in the diagnosis of Acute Myocardial Infarction (AMI).

    The In Vitro Nano-Check ™ AMI cTnl Test is a qualitative assay, which cannot monitor the rise and fall of cTnl in single testing. Single testing is not recommended for AMI monitoring. Test results should be interpreted by the physician in conjunction with other test results and patient clinical findings.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification approval letter for the "In Vitro Nano-Check™ AMI cTnI Cardiac Marker Test". It confirms that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain any information regarding acceptance criteria, study details, performance data, sample sizes, expert qualifications, ground truth establishment, or any other specifics related to a device performance study.

    Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or other study details based on the provided input. The document is an FDA approval letter, not a study report.

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