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510(k) Data Aggregation

    K Number
    K042807
    Device Name
    ADVIA IMS VALPROIC ACID METHOD
    Manufacturer
    BAYER HEALTHCARE, LLC
    Date Cleared
    2005-02-08

    (119 days)

    Product Code
    LEG,DKB
    Regulation Number
    862.3645
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ADVIA IMS VALPROIC ACID METHOD

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

    This in vitro method is intended to quantitatively measure the antiepileptic drug valproic acid in human serum and plasma on the Bayer ADVIA® IMS systems. Measurements of valproic acid are used to aid in monitoring therapeutic levels of valproic acid to ensure appropriate therapy and in the treatment of valproic acid overdose.
    The Bayer ADVIA IMS Valproic Acid method is for in vitro diagnostic use to measure the antiepileptic drug valproic acid in human serum and plasma. Measurements of valproic acid (2-propylpentanoic acid) are used as an aid in the diagnosis and treatment of valproic acid overdose, and in monitoring therapeutic levels of valproic acid to ensure appropriate therapy.

    Device Description

    Not Found

    AI/ML Overview

    1. Acceptance Criteria and Reported Device Performance

    Performance MetricAcceptance Criteria (Implied)Reported Device Performance (ADVIA IMS)Predicate Device Performance (Centaur)
    Minimum Detectable Concentration (MDC)Lower than or comparable to predicate device.0.57 µg/mL1.0 µg/mL
    Imprecision (Total CV%)Comparable to or better than predicate device (lower CV%).Level 34.03: 4.4%
    Level 70.16: 2.9%
    Level 98.86: 2.0%Level 22.8: 6.9%
    Level 64.6: 6.1%
    Level 102.7: 6.4%
    Correlation (R value)High correlation (close to 1) with the predicate device.0.997N/A (Comparison System)
    Regression Equation (Slope)Close to 1 (indicating proportional agreement).0.98N/A (Comparison System)
    Regression Equation (Y-intercept)Close to 0 (indicating minimal constant bias).4.9N/A (Comparison System)
    Syx µg/mL (Standard error of estimate)Low, indicating good agreement between methods.3.1N/A (Comparison System)
    Interfering SubstancesEffects of interfering substances should be minimal (e.g., % change
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