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510(k) Data Aggregation

    K Number
    K983492
    Device Name
    BOEHRINGER MANNHEIM ELECSYS PRESICONTROL CARDIAC
    Manufacturer
    BOEHRINGER MANNHEIM CORP.
    Date Cleared
    1998-10-09

    (4 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K962575
    Why did this record match?
    Device Name :

    BOEHRINGER MANNHEIM ELECSYS PRESICONTROL CARDIAC

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

    Elecsys ® PreciControl Cardiac is used for quality control of the Elecsys CK-MB, Troponin T (CARDIAC T®) and Myoglobin immunoassays using the Elecsys immunoassay systems.

    Device Description

    Boehringer Mannheim Elecsys ® PreciControl Cardiac is a bilevel lyophilized preparation of pooled human sera containing CK-MB (human), Troponin T (human recombinant) and Myoglobin (human) for monitoring the accuracy and precision of Elecsys CK-MB, Troponin T and Myoglobin immunoassays.

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) summary for a quality control device (Boehringer Mannheim Elecsys ® PreciControl Cardiac), not a medical device that performs a diagnostic function.

    Therefore, the concepts of "acceptance criteria," "device performance," "study," "sample size for test set," "data provenance," "number of experts," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "ground truth type," "training set sample size," and "how ground truth for training set was established" are not applicable in the context of this document.

    This document describes a control material used to monitor the accuracy and precision of immunoassay systems, not a device that generates diagnostic results itself.

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