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    K Number
    K992711
    Device Name
    SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094
    Manufacturer
    SIGMA DIAGNOSTICS, INC.
    Date Cleared
    1999-12-06

    (117 days)

    Product Code
    GFO
    Regulation Number
    864.7925
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094

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

    Sigma Diagnostics ALEXIN™ HS is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.

    Device Description

    Sigma Diagnostics ALEXIN 14 HS contains purified rabbit brain and soy phospholipids with an ellagic acid activator for the determination of the activated partial thromboplastin time and related coagulation procedures in citrated plasma.

    AI/ML Overview

    Sigma Diagnostics ALEXIN™ HS is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway. The study aimed to demonstrate its substantial equivalence to Dade Actin-FS.

    1. Table of acceptance criteria and reported device performance:

    The document doesn't explicitly state "acceptance criteria" in a numerical sense, but rather demonstrates substantial equivalence through correlation and regression with a predicate device, and provides precision data. For the purpose of this analysis, we will infer the acceptance criteria from the reported performance, implying that the achieved correlation and precision were considered acceptable for substantial equivalence.

    MetricAcceptance Criteria (Inferred from Predicate Equivalence)Reported Device Performance (ALEXIN™ HS)
    Correlation with Dade Actin-FS (Optical Mode)High correlation (e.g., > 0.95 or similar to predicate)0.97
    Correlation with Dade Actin-FS (Mechanical Mode)High correlation (e.g., > 0.95 or similar to predicate)0.97
    Correlation on KC 4A analyzerHigh correlation (e.g., > 0.95 or similar to predicate)0.96
    Regression Equation (Optical Mode)Regression line close to y = x (i.e., slope ≈ 1, intercept ≈ 0)y = 0.81 x + 0.31
    Regression Equation (Mechanical Mode)Regression line close to y = x (i.e., slope ≈ 1, intercept ≈ 0)y = 0.84 x + 0.28
    Regression Equation (KC 4A analyzer)Regression line close to y = x (i.e., slope ≈ 1, intercept ≈ 0)y = 0.94 x + 0.08
    Within-Run Precision (Control I CV%)Low variability (e.g., typically
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