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    K Number
    K020807
    Device Name
    AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
    Manufacturer
    BAYER DIAGNOSTICS CORP.
    Date Cleared
    2002-10-01

    (203 days)

    Product Code
    LOJ
    Regulation Number
    866.6010
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

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

    The Bayer ADVIA® IMS™ AFP assay is an in vitro diagnostic device intended to quantitatively measure afetoprotein (AFP) in human serum on the Bayer ADVIA IMS system as an aid in the management of nonseminomatous testicular cancer. AFP values obtained using the Bayer ADVIA IMS assay method must be interpreted in conjunction with all other available clinical and laboratory data before a medical decision is determined. AFP testing is not recommended as a screening procedure to detect cancer in the general population.

    Device Description

    The Bayer ADVIA® IMS™ AFP assay is an in vitro diagnostic device intended to quantitatively measure afetoprotein (AFP) in human serum on the Bayer ADVIA IMS system.

    AI/ML Overview

    Acceptance Criteria and Study for Bayer ADVIA® IMS™ AFP Assay

    This document summarizes the acceptance criteria and the study conducted to demonstrate the safety and effectiveness of the Bayer ADVIA® IMS™ AFP Assay.

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria for the ADVIA IMS AFP Assay are primarily established by demonstrating substantial equivalence to the predicate device, Immuno 1 AFP Assay, across various performance metrics. The specific quantitative acceptance criteria are implicitly defined by the reported performance metrics of the predicate device and the observed performance of the new device.

    Performance MetricAcceptance Criteria (Implicit, based on predicate performance)Reported Device Performance (ADVIA IMS AFP Assay)
    Imprecision (Total CV%)Comparable to Immuno 1Level 4.6 ng/mL: 2.3%
    Level 18.97 ng/mL: 2.7%
    Level 93.52 ng/mL: 2.6%
    Correlation: Regression Equation (Y=ADVIA IMS, X=Immuno 1)Close to Y=X (slope ~1, intercept ~0)Y = 1.06 * X - 3.18
    Correlation: SyxLow Syx, indicating good agreement5.82 ng/mL
    Correlation: R (correlation coefficient)High (close to 1)0.998
    Interfering Substances (Effect % change)Effect within acceptable limits (typically
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