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    K Number
    K965092
    Device Name
    VIDAS ROTAVIRUS ASSAY
    Manufacturer
    BIOMERIEUX VITEK, INC.
    Date Cleared
    1997-05-05

    (137 days)

    Product Code
    LIQ
    Regulation Number
    866.3405
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VIDAS ROTAVIRUS ASSAY

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

    The VIDAS Rotavirus (RTV) Assay detects the presence of rotavirus antigen in stool specimens.

    Device Description

    The VIDAS RTV Assay detects the presence of rotavirus antigen in stool specimens. Assay specificity is conferred by the use of two antibodies. The rotavirus antigen is captured on the SPR by a polyclonal anti-rotavirus VP6 antibody, and the detector antibody conjugate is composed of a mouse monoclonal anti-rotavirus VP6 antibody.

    AI/ML Overview

    Here's an analysis of the provided text, focusing on the acceptance criteria and study details for the VIDAS Rotavirus Assay:

    Acceptance Criteria and Study Details for the VIDAS Rotavirus Assay

    This submission describes the VIDAS Rotavirus Assay, a diagnostic device for detecting rotavirus antigen in stool specimens. The primary study presented here is a standalone performance evaluation comparing the VIDAS RTV Assay to a commercially available EIA, with discrepancies resolved by a second EIA and electron microscopy (EM).

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Pivotal Study-Based Acceptance Criteria:
    Relative Specificity (compared to primary EIA with discrepancy resolution)95.1%
    Relative Sensitivity (compared to primary EIA with discrepancy resolution)96.4%
    Overall Agreement (compared to primary EIA with discrepancy resolution)96.5%
    Overall Agreement (after EM resolution of all discrepant samples)94.8%
    Number of Equivocal Results (following package insert instructions)4
    Number of Invalid Results (following package insert instructions)0
    Cross-reactivity/Interference (with approx. 50 microorganisms)No cross-reactivity or interference observed.
    Intra-assay Precision (Coefficient of Variation)
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