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    K Number
    K981748
    Device Name
    WIELISA ANCA SCREENING KIT TEST SYSTEM
    Manufacturer
    WIESLAB AB
    Date Cleared
    1998-07-22

    (65 days)

    Product Code
    MOB
    Regulation Number
    866.5660
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    WIELISA ANCA SCREENING KIT TEST SYSTEM

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

    The Wielisa ANCA Screening Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of antibodies to Proteinase-3 (PR-3) and Myeloperoxidase (MPO) in human sera. The assay is used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of systemic vasculitis, especially Wegener's granulomatosis (WG) and microcopic polyangiitis (MP). The assay is intended for use in patients with signs and symptoms consistent with systemic vasculitis. It is not intended for screening a healthy population. A positive result should always be confirmed by a semi-quantitative assay.

    Device Description

    The Wielisa ANCA Screening Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of antibodies to Proteinase-3 (PR-3) and Myeloperoxidase (MPO) in human sera. The assay is used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of systemic vasculitis, especially Wegener's granulomatosis (WG) and microcopic polyangiitis (MP). The assay is intended for use in patients with signs and symptoms consistent with systemic vasculitis. It is not intended for screening a healthy population. A positive result should always be confirmed by a semi-quantitative assay.

    The wells of the microtiter strips are coated with purified (Human Neutrophil source) proteinase 3, and MPO (Human Neutrophil source) antigen. During the first incubation, specific antibodies in diluted serum, will bind to the antigen coating.

    The wells are then washed to remove unbound antibodies and other components. A conjugate of alkaline phosphatase-labeled (Goat) antibodies to human IgG binds to the antibodies in the wells in this second incubation.

    After a further washing step, detection of specific antibodies is obtained by incubation with substrate solution. The amount of bound antibodies correlates to the color intensity and is measured in terms of absorbance (optical density (OD)). The absorbance is then calculated and the results are given as a ratio to the negative control.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and study detailed in the provided document:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for sensitivity or specificity. However, it presents the results of a comparative study against clinical characterization and a predicate semi-quantitative ELISA. We can infer the performance targets based on the documented predicate device equivalence. For the purpose of this response, I'll interpret the "acceptance criteria" as meeting or exceeding the performance of the predicate devices or demonstrating high clinical validity.

    Performance MetricSpecificity/ThresholdAcceptance Criteria (Inferred)Reported Device Performance
    Clinical Sensitivity - PR3-ANCAWG samplesHigh (e.g., >80%)92.9% (95% CI: 84.9-100%)
    MP samplesModerate (e.g., >50%)51.2% (95% CI: 35.6-66.8%)
    Clinical Sensitivity - MPO-ANCAWG samplesLow (e.g., 40%)46.5% (95% CI: 31.3-61.7%)
    Clinical Specificity - PR3-ANCASLEVery High (e.g., >95%)100% (95% CI: 90.4-100%)
    RAVery High (e.g., >95%)100% (95% CI: 92.7-100%)
    NS (Blood Donors)Very High (e.g., >95%)100% (95% CI: 97.6-100%)
    Clinical Specificity - MPO-ANCASLEHigh (e.g., >80%)82.8% (95% CI: 68.7-96.8%)
    RAVery High (e.g., >95%)100% (95% CI: 92.6-100%)
    NS (Blood Donors)Very High (e.g., >95%)100% (95% CI: 97.6-100%)
    Relative Sensitivity - PR3-ANCA (vs. Semi-quantitative ELISA)(Implied equivalence)High (e.g., >95%)98.3% (95% CI: 95.0-100%)
    Relative Sensitivity - MPO-ANCA (vs. Semi-quantitative ELISA)(Implied equivalence)High (e.g., >95%)95.8% (95% CI: 87.7-100%)
    Relative Specificity - PR3-ANCA (vs. Semi-quantitative ELISA)(Implied equivalence)Very High (e.g., >98%)100% (95% CI: 98.0-100%)
    Relative Specificity - MPO-ANCA (vs. Semi-quantitative ELISA)(Implied equivalence)Very High (e.g., >98%)100% (95% CI: 98.4-100%)
    Batch to Batch Variation (CV%)PR3-ANCALow (e.g.,
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