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510(k) Data Aggregation

    K Number
    K072617
    Device Name
    ELECSYS RUBELLA IGG IMMUNOASSAY
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Date Cleared
    2008-12-05

    (445 days)

    Product Code
    LFX,JJX
    Regulation Number
    866.3510
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    K983805,K984180
    Why did this record match?
    Device Name :

    ELECSYS RUBELLA IGG IMMUNOASSAY

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

    (1) The Elecsys Rubella IgG immunoassay is for the in vitro quantitative determination of IgG antibodies to rubella virus in human serum and Li-heparin, K3-EDTA and sodium citrate plasma.
    This assay may be used as an aid in the assessment of immune status to rubella in individuals including women of childbearing age.
    The electrochemiluminescence immunoassay "ECLIA" is intended for use or Elecsys and cobas e immunoassay analyzers.
    (2) Elecsys PreciControl Rubella IgG is used for quality control of the Elecsys Rubella IgG immunoassay on the Elecsys and cobas e immunoassay analyzers.

    Device Description

    (1) The Elecsys Rubella IgG Immunoassay is a two-step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. The Rubella IgG assay contains: a biotin labeled monoclonal antibody against human IgG, a ruthenium-labeled anti-Rubella antibody fragment , biotin- and ruthenium-labeled Rubella-antigens and a Rubella-like particle. A relationship exists between the concentration of the IgG antibody targets present in a patient sample and the level of signal count detected by the system. The IgG assay is quantitative and is standardized against WHO materials. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve provided with the reagent bar code. The test kit contains the human serum-based calibrators intended for use with the system.
    (2) The Elecsys Precicontrol Rubella IgG contains two levels of human serum with Rubella IgG antibodies.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and supporting studies for the Elecsys Rubella IgG Immunoassay, based on the provided 510(k) summary:

    1. Table of Acceptance Criteria and Reported Device Performance

    The 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device, rather than explicit pre-defined acceptance criteria in terms of numerical thresholds for performance metrics. However, we can infer performance goals based on the presented data and the comparison to the predicate device.

    Performance MetricAcceptance Criteria (Implied/Achieved for Substantial Equivalence)Reported Device Performance (Elecsys Rubella IgG Immunoassay)
    Method Comparison (vs Predicate: Zeus Scientific Rubella IgG ELISA Test System)Agreement with predicate device demonstrating similar clinical utility.See detailed breakdown below in "Study Details".
    Limit of Blank (LoB)As low as possible to ensure accurate negative results.5 IU/mL: CV 1.64–8.21%
    Precision (Inter-assay)Low variability across different assay runs.Low Control: SD 0.118-0.319 IU/mL; High Control: CV 3.35-7.69 %; Plasma Samples 5 IU/mL: CV 2.08–9.54%
    Analytical SpecificityHigh agreement in the presence of various disease states.96.6 % agreement with predicate for 60 specimens representing a variety of disease states.
    InterferencesRecovery of positive samples within ± 20% of initial value. Assayed for icterus, hemolysis, lipemia, Immunoglobulin A, biotin, rheumatoid factors, and Rubella-specific Immunoglobulin M.Unaffected by icterus (
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