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510(k) Data Aggregation

    K Number
    K013637
    Device Name
    ACTICHROME HEPARIN (ANTI-FIIA)
    Manufacturer
    AMERICAN DIAGNOSTICA, INC.
    Date Cleared
    2002-04-16

    (162 days)

    Product Code
    KFF
    Regulation Number
    864.7525
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    K972209
    Why did this record match?
    Reference Devices :

    K972209

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

    ACTICHROME® Heparin (anti-fila) is a chromogenic assay intended for the quantitative determination of therapeutic heparin in human plasma by measurement of factor IIa (thrombin) inhibition. The Electra 900C® was used to determine performance data. This kit is for in vitro diagnostic use.

    Device Description

    ACTICHROME® Heparin (anti-fIIa) Product No. 820

    AI/ML Overview

    The provided text describes a 510(k) summary for the ACTICHROME® Heparin (anti-fIIa) assay. It focuses on demonstrating substantial equivalence to a predicate device, primarily through method comparison and precision studies.

    Here's an analysis based on your requested information:

    1. Table of Acceptance Criteria and Reported Device Performance:

    The document doesn't explicitly state "acceptance criteria" in a numerical or categorical format for demonstrating substantial equivalence. Instead, it relies on a strong "positive correlation" with the predicate device and acceptable precision (CV%).

    Performance MetricAcceptance Criteria (Implied/General)Reported Device Performance (ACTICHROME Heparin (anti-fIIa))
    Method ComparisonStrong positive correlation (e.g., R-value > 0.9) and regression equation demonstrating agreement with predicate.Lot 010 (N=88): R = 0.967, Y = 0.845X + 0.027
    Lot 010 (N=32): R = 0.917, Y = 0.764X + 0.032
    Sy.x (ng/ml) = 0.03 (N=88), 0.05 (N=32)
    Intra-Assay Precision (CV%)Low variability (e.g., typically
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