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    K Number
    K014105
    Device Name
    SPECTRAL'S TROPONIN I
    Manufacturer
    SPECTRAL DIAGNOSTICS, INC.
    Date Cleared
    2002-02-01

    (50 days)

    Product Code
    MMI
    Regulation Number
    862.1215
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SPECTRAL'S TROPONIN I

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

    The Spectral's Troponin I test is intended for use as an in vitro diagnostic product for the rapid quantitative determination of cardiac troponin I in human whole blood, serum, and plasma. The test is used as an aid in the diagnosis of myocardial infarction in emergency room, critical care, point of care and hospital settings.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for "Spectral's Troponin I Test," an in vitro diagnostic device. This document does not contain the detailed information required to answer your prompt regarding acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment for an AI/device performance study.

    The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It discusses regulatory classifications, general controls, and directs the manufacturer to various FDA offices for further information on labeling, promotion, and other responsibilities.

    Therefore, I cannot extract the requested information from the provided text. The document does not describe a study that proves the device meets acceptance criteria in the way you've outlined for an AI/device performance evaluation.

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