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    K Number
    K992712
    Device Name
    SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334
    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 LS, MODELS A1219, A1334

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

    Sigma Diagnostics ALEXIN™ LS is a device used for primary screening for coagulation Shina Diagnest of evaluation of the effect of therapy on procoagulant disorders, and as able mail.com factor deficiencies of the intrinsic coagulation pathway.

    Device Description

    Sigma Diagnostics ALEXIN™ LS contains purified rabbit brain and sov phospholipids with an ellagic acid activator for the determination of the activated partial thromboplastin time and related coagulation procedures in citrated plasma. This reagent has increased sensitivity to lupus anticoagulants.

    AI/ML Overview

    The provided document describes the safety and effectiveness study for the Sigma Diagnostics ALEXIN™ LS device, demonstrating its substantial equivalence to the Dade Actin-FSL device.

    Here's a breakdown of the requested information:

    1. Table of Acceptance Criteria and Reported Device Performance:

    The primary acceptance criteria for this device appear to be a strong correlation and agreement with a legally marketed predicate device (Dade Actin-FSL). The precision data also represents performance within expected ranges for such assays.

    Acceptance Criteria CategorySpecific Criteria (Implied)Reported Device Performance (ALEXIN™ LS vs. Dade Actin-FSL)
    Correlation CoefficientHigh correlation (e.g., > 0.90) between ALEXIN™ LS and predicate deviceOptical Mode: 0.97
    Mechanical Mode: 0.98
    KC 4A Analyzer: 0.95
    Regression Equation (Slope/Intercept)Close agreement (slope near 1, intercept near 0)Optical Mode: y = 0.91x + 0.10
    Mechanical Mode: y = 0.92x + 0.08
    KC 4A Analyzer: y = 0.86x + 0.15
    Precision (Within-Run CV%)Low variability (typically
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