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510(k) Data Aggregation

    K Number
    K013062
    Device Name
    BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT
    Manufacturer
    BIOCHECK, INC.
    Date Cleared
    2002-01-08

    (118 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 BioCheck cTnI ELISA 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

    This document is a 510(k) clearance letter for the BioCheck, Inc. Human Cardiac Troponin I Enzyme Immunoassay Test Kit. It states that the device is substantially equivalent to legally marketed predicate devices, but it does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot provide the requested information from this document.

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