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510(k) Data Aggregation

    K Number
    K061820
    Device Name
    DIASORIN LIAISON VZV IGG
    Manufacturer
    DIASORIN, INC.
    Date Cleared
    2007-02-26

    (243 days)

    Product Code
    LFY,PRE
    Regulation Number
    866.3900
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    K981867
    Why did this record match?
    Reference Devices :

    K981867

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

    The LIAISON® VZV IgG Assay uses chemiluminescence immunoassay (CLIA) technology on the LIAISON® Analyzer for the qualitative detection of specific IgG antibodies to varicella-zoster virus in human serum. This assay can be used as an aid in the determination of previous infection of varicella-zoster virus.

    Device Description

    The method for the qualitative determination of specific IgG to varicella- zoster virus is an indirect chemiluminescence immunoassay (CLIA). All assay steps and incubations are performed by the LIAISON® Analyzer.

    Varicella-zoster virus antigen is used for coating magnetic particles (solid phase) and a mouse monoclonal antibody to human IgG is linked to an isoluminol derivative (isoluminol-antibody conjugate). During the first incubation, anti-VZV IgG antibodies, present in calibrators, samples or controls, bind to the solid phase. After each incubation, the unbound material is removed with a wash cycle. During the second incubation, the antibody conjugate reacts with anti-VZV IgG already bound to the solid phase. Subsequently, the starter reagents are added and a flash chemiluminescence reaction is induced. The light signal, directly related to the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is indicative of the presence of anti-VZV IgG in calibrators, samples or controls.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the DiaSorin LIAISON® VZV IgG device, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are implied by the clinical trial results. The device aims to demonstrate substantial equivalence to the predicate device.

    MetricAcceptance Criteria (Implied)Reported Device Performance (General Samples)Reported Device Performance (Pregnant Women)
    Positive AgreementHigh agreement with predicate device for positive samples98.8% (97.7 - 99.5% 95% CI)99.2% (98.2 - 99.7% 95% CI)
    Negative AgreementHigh agreement with predicate device for negative samples84.4% (74.4 - 91.7% 95% CI)64.1% (47.6 - 78.8% 95% CI)
    Overall ReproducibilityConsistent results across runs, sites, and operators (low %CV)See detailed tables belowSee detailed tables below
    Assay PrecisionConsistent results over time on a single instrument (low %CV)See detailed tables belowSee detailed tables below

    Reproducibility (3-site, 5-day study with 3 kit lots):

    ID#NMean Index (Overall %CV)
    DiaSorin Neg Ctl6030.3 (18.6)
    DiaSorin Pos Ctl60434 (14.4)
    011006 (Cutoff Ctl)60246 (13.8)
    BR Neg Ctl (100% serum)60
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