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510(k) Data Aggregation

    K Number
    K973823
    Device Name
    PR 3 ANTIBODY KIT
    Manufacturer
    HEMAGEN DIAGNOSTICS, INC.
    Date Cleared
    1997-11-13

    (37 days)

    Product Code
    MOB
    Regulation Number
    866.5660
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    K954105
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This enzyme-linked immunosorbent assay (ELISA) is indicated for the detection of autoantibodies to the antigen Proteinase 3 in human serum. The presence of PR-3 antibodies, in combination with clinical observations and other serological tests, can aid in the diagnosis of Wegener's granulomatosis (WG) and other conditions associated with elevated anti-neutrophil cytoplasmic antibodies (ANCA)

    Device Description

    An enzyme-linked immunosorbent assay (ELISA) designed for the detection and measurement of autoantibodies to the antigen Proteinase 3 in human serum. The ELISA methodology is commonly used for serum antibody evaluations. Purified PR3 antigen has been attached to the inner surfaces of the microwell plate. During the initial incubation step, antibodies in patient serum bind specifically to the immobilized antigen and remain in place after a wash step. A second antibody which is conjugated to horseradish peroxidase (HRP) is used to recognize the "heavy + light" chain regions of the patient's antibodies remaining after the wash step. In the wells where the second antibody remains bound, the conjugated HRP catalyzes a color change in the substrate, tetramethyl benzidine (TMB). After the reaction is stopped, the color is read in an EIA Plate reader.

    AI/ML Overview

    The provided 510(k) summary for K973823 describes a VIRGO® cANCA Kit, an enzyme-linked immunosorbent assay (ELISA) designed to detect autoantibodies to Proteinase 3 (PR3) in human serum. This test is intended as an aid in the diagnosis of current or past autoimmune-mediated vasculitides, specifically Wegener's granulomatosis.

    Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The submission does not explicitly state pre-defined acceptance criteria in terms of specific sensitivity, specificity, or agreement percentages. Instead, the performance is reported as a comparison to a predicate device. The implied acceptance criterion is "substantial equivalence" to the predicate device, which is demonstrated by a high level of agreement.

    Performance MetricAcceptance Criteria (Implied)Reported Device Performance (VIRGO® cANCA Kit)
    Comparative TestingSubstantial equivalence to the predicate device (Scimedx ANTI-PR3 ANTIBODY EIA), demonstrated by high agreement (sensitivity and specificity).
    Relative SensitivityN/A (implied high)100.0% (28/28)
    Relative SpecificityN/A (implied high)100.0% (80/80)
    Precision (Inter-assay)Low coefficient of variation (%CV)%CV for OD: 6.6% - 11.5%
    %CV for Units: 7.9% - 12.3%
    Precision (Intra-assay)Low coefficient of variation (%CV)%CV for OD: 3.7% - 6.9%
    %CV for Units: 3.7% - 6.7%
    Interfering SubstancesNo significant interference below specified concentrationsHemoglobin
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