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    K Number
    K981163
    Device Name
    DIAMEDIX IS-CMV IGG TEST SYSTEM
    Manufacturer
    DIAMEDIX CORP.
    Date Cleared
    1998-09-21

    (174 days)

    Product Code
    LFZ,LF7
    Regulation Number
    866.3175
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DIAMEDIX IS-CMV IGG TEST SYSTEM

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

    The Diamedix Is-CMV IgG an Enzyme Immunoassay (EIA) for the qualitative and semi-quantitative determination of IgG antibodies in human serum by EIA to aid in the assessment of the patient's immunological response to CMV and to determine the immune status of individuals, including females of child-bearing age. The evaluation of acute and convales of child-bearing age. The evaluation of aculture infection, reactivated infection, or resident of primary infection, reactiveled infection, or reinfection with CMV. These reagents can be used either manually or in conjunction with CMV. These reage Automated EIA Processor Automated EIA Processor.

    Device Description

    The Is-CMV IgG Test System is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG to CMV antigen in human serum

    AI/ML Overview

    Acceptance Criteria and Device Performance for the Diamedix Is-CMV IgG Test System

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided document does not explicitly state pre-defined acceptance criteria (e.g., "the device must achieve a sensitivity of at least X%"). Instead, it presents performance characteristics from comparison studies and other tests. The "reported device performance" below highlights key metrics from these studies.

    Performance MetricAcceptance Criteria (Not explicitly stated, but implied by regulatory submission)Reported Device Performance (Range across studies/sites)
    Relative SensitivityHigh agreement with predicate device96.6% - 100.0%
    Relative SpecificityHigh agreement with predicate device87.8% - 100.0%
    Overall AgreementHigh agreement with predicate device97.0% - 99.0%
    Correlation: Manual vs. MAGO PlusStrong positive correlation (e.g., R-value close to 1)R-value: 0.9568
    CDC Serum Panel AgreementHigh agreement with CDC results (masked characterized panel)99% total agreement; 100% agreement for positive and negative samples (both manual and automated)
    LinearityDemonstrated linearity throughout reportable rangeRepresentative graphs show linearity over reportable range (R-values > 0.99)
    Cross-ReactivityNo significant cross-reactivity with common interfering virusesNo cross-reactivity detected with various IgG antibodies (VZV, HSV 1/2, Toxoplasma, Rubella, EBV, Measles)
    Precision (Interassay CV%)Acceptable variability (generally
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