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510(k) Data Aggregation

    K Number
    K022178
    Device Name
    CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
    Manufacturer
    BAYER DIAGNOSTICS CORP.
    Date Cleared
    2002-11-12

    (132 days)

    Product Code
    MOI,JIT
    Regulation Number
    866.6010
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This in vitro immunoassay is intended to quantitavely measure CA 15-3 values in human serum. When used in conjunction with other clinical and diagnostics procedures, serial testing using ADVIA IMS CA 15-3 Assay on a Bayer ADVIA® IMS ™, is indicated for monitoring the course of disease and therapy in metastatic breast cancer patients, and for the detection of recurrence in previously treated Stage II, with greater than two positive lymph nodes, or Stage III breast cancer patients.

    Device Description

    Not Found

    AI/ML Overview

    The information provided describes the performance of the CA 15-3 Assay for the Bayer ADVIA® Integrated Modular System (IMS)™ as part of a 510(k) premarket notification. This submission focuses on demonstrating substantial equivalence to a predicate device, rather than a clinical study evaluating the device's impact on human readers or clinical outcomes.

    Here's an analysis of the provided information, structured according to your request:

    Acceptance Criteria and Device Performance

    The provided document doesn't explicitly state "acceptance criteria" for each performance metric as a numerical threshold, but rather presents the device's performance characteristics with the implicit understanding that these values are considered acceptable for substantial equivalence to the predicate device. The conclusion explicitly states: "Performance of the ADVIA IMS CA 15-3 Assay on a a Bayer ADVIA® IMS ™ is equivalent to the performance of the CA 15-3 Assay on the predicate device (Immuno 1) and is within proposed specifications."

    Performance CharacteristicAcceptance Criteria (Implicit from Predicate & Equivalence)Reported Device Performance (ADVIA IMS CA 15-3 Assay)
    ImprecisionComparable to predicate device (Immuno 1)Level 1 (12.3 U/mL): 4.7% Total CV
    Level 2 (29.6 U/mL): 5.5% Total CV
    Level 3 (59.1 U/mL): 5.3% Total CV
    Correlation (vs. Predicate Immuno 1)Strong linear correlation with predicate device (e.g., R-value close to 1, Syx indicating low scatter)N = 73 serum specimens
    Regression Equation: $1.061 * X + 1.50$ (Y=ADVIA IMS, X=Immuno 1)
    Syx (U/mL): 3.04
    R (Correlation Coefficient): 0.996
    Sample Range: 7.02 - 184.9 U/mL
    Interfering Substances (Effect % change)Minimal effect (generally
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