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    K Number
    K983178
    Device Name
    COAMATIC HEPARIN
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Date Cleared
    1998-11-03

    (53 days)

    Product Code
    KFF
    Regulation Number
    864.7525
    Type
    Traditional
    Panel
    Hepatology / Hepatic (HE)
    Reference & Predicate Devices
    K980242
    Why did this record match?
    Device Name :

    COAMATIC HEPARIN

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

    Coamatic® Heparin is an in vitro diagnostic test for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma using automated and microplate methods. The amount of UFH or LMWH is determined from the anti-FXa activity expressed by the [AT*Heparin] complex formed in plasma.

    Device Description

    Coamatic® Heparin is an in vitro diagnostic test for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma using automated and microplate methods.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Coamatic® Heparin device, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are not explicitly stated as numerical targets in the provided document. Instead, the study aims to demonstrate "substantial equivalence in its performance" to the predicate device (IL Test™ Heparin). This is primarily assessed through correlation studies, where a slope close to 1, an intercept close to 0, and a high correlation coefficient (r) indicate substantial equivalence. Precision is also evaluated using %CV.

    Therefore, the acceptance criteria are inferred from what constitutes "substantially equivalent performance" in such comparative studies.

    Performance MetricAcceptance Criteria (Inferred)Reported Device Performance
    Comparative Studies (vs. Predicate IL Test™ Heparin)
    SlopeClose to 1.00 (e.g., 0.90 to 1.10)Range: 0.91 to 1.04
    InterceptClose to 0.00 (e.g., -0.10 to 0.10)Range: -0.01 to 0.06
    Correlation (r)High (e.g., ≥ 0.95)Range: 0.97 to 0.99
    Precision (Microplate Method)
    Within Run %CV (UFH)Low (e.g.,
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