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510(k) Data Aggregation

    K Number
    K013318
    Device Name
    ACTICHROME HEPARIN (ANTI-FXA), MODEL 832
    Manufacturer
    AMERICAN DIAGNOSTICA, INC.
    Date Cleared
    2002-03-08

    (154 days)

    Product Code
    KFF
    Regulation Number
    864.7525
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    K923499
    Why did this record match?
    Device Name :

    ACTICHROME HEPARIN (ANTI-FXA), MODEL 832

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

    ACTICHROME® Heparin (anti-fXa) is a chromogenic assay intended for the quantitative determination of unfractionated and low molecular weight heparins in human plasma. The assay measures the inhibition of factor Xa (fXa) activity by the various heparins. The Electra 900C® was used to determine performance data. This kit is for in vitro diagnostic use.

    Device Description

    ACTICHROME® Heparin (anti-fXa) is a chromogenic assay intended for the quantitative determination of unfractionated and low molecular weight heparins in human plasma. The assay measures the inhibition of factor Xa (fXa) activity by the various heparins.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for the ACTICHROME® Heparin (anti-fXa) device:

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided text does not explicitly state pre-defined acceptance criteria (e.g., "The device must achieve an R-value of at least X"). Instead, it presents performance data and implies that equivalence to the predicate device is the overarching acceptance criterion. Thus, the "acceptance criteria" are inferred from the demonstrated performance in comparison to the predicate.

    Acceptance Criteria (Inferred from Predicate Equivalence)Reported Device Performance (ACTICHROME Heparin (anti-fXa))
    Method Comparison vs. Predicate Device
    Positive correlation with predicate device (implied R > 0.8)Unfractionated Heparin (Lot 007): R = 0.913, Y = 0.843X + 0.003, Sy.x = 0.07
    Unfractionated Heparin (Lot 010): R = 0.859, Y = 0.765X - 0.009, Sy.x = 0.08
    LMW Heparin (Lot 010): R = 0.895, Y = 1.363X - 0.139, Sy.x = 0.14
    Precision (Intra-Assay CV%)
    Maintain low intra-assay variability (implied
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