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    K Number
    K971909
    Device Name
    VIRGO AMA ELISA KIT
    Manufacturer
    HEMAGEN DIAGNOSTICS, INC.
    Date Cleared
    1997-06-20

    (28 days)

    Product Code
    DBM
    Regulation Number
    866.5090
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VIRGO AMA ELISA KIT

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

    This enzyme-linked immunosorbent assay (ELISA) is indicated for the detection and measurement of antimitochondrial antibodies in human serum. The presence of mitochondrial antibodies, in combination with clinical observations and other serological tests, can aid in the diagnosis of primary biliary cirrhosis(PBC)

    Device Description

    An enzyme-linked immunosorbent assay (ELISA) designed for the detection and measurement of antibodies to mitochondrial antigen in human serum. The ELISA methodology is commonly used for serum antibody evaluations. Purified mitochondrial 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 document describes the VIRGO® AMA ELISA KIT, an enzyme-linked immunosorbent assay designed for the detection and measurement of antimitochondrial antibodies in human serum. This device is intended to aid in the diagnosis of primary biliary cirrhosis (PBC) when used in combination with clinical observations and other serological tests.

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly state pre-defined acceptance criteria with numerical targets. However, based on the comparative testing and precision studies, the implied criteria are:

    Acceptance Criteria CategoryImplied Acceptance Criteria (Based on context)Reported Device Performance (VIRGO® AMA ELISA KIT)
    Precision (Inter-assay)Demonstrates consistency across different assaysMean % CV for positive samples (OD): 4.9 - 11.0%
    Mean % CV for positive samples (Units): 9.9 - 15.9%
    Negative samples: N/A due to low OD values.
    Precision (Intra-assay)Demonstrates consistency within a single assay runMean % CV for positive samples (OD): 2.7 - 8.5%
    Mean % CV for positive samples (Units): 9.1 - 13.7%
    Negative samples: N/A due to low OD values.
    Comparative Testing (Sensitivity)High agreement with predicate device for positive samples from individuals with known or suspected liver disease.Relative Sensitivity = 100.0% (61/61) with 94.1% to 100% confidence interval.
    Comparative Testing (Specificity)High agreement with predicate device for negative samples from apparently healthy donors.86 out of 86 normal samples were negative, indicating 100% agreement with the predicate device for this cohort.
    Interfering SubstancesNo significant effect (
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