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510(k) Data Aggregation

    K Number
    K071511
    Device Name
    PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MODEL MP0900G
    Manufacturer
    FOCUS DIAGNOSTICS, INC.
    Date Cleared
    2007-10-05

    (123 days)

    Product Code
    MXJ,MYF
    Regulation Number
    866.3305
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Focus Diagnostics Plexus™ HerpeSelect® HSV 1 and 2 IgG (with software) is intended for qualitatively detecting the presence or absence of human IgG antibodies to HSV-1 and HSV-2 in human sera. The test is indicated for pregnant women and sexually active adults, as an aid for presumptively diagnosing HSV-1 and HSV-2 infection. The predictive value of a positive or negative result depends on the population's prevalence and the pretest likelihood of HSV-1 and HSV-2 infection. The test is not intended for donor screening or for self-testing. The performance of this assay has not been established for use in a pediatric population, for neonatal screening, for testing of immunocompromised patients, for use by a point of care facility or for use with automated equipment.

    Device Description

    The Focus Diagnostics Plexus™ HerpeSelect® HSV 1 and 2 IgG (with software) is a multiplexed immunoassay for qualitatively detecting and differentiating human IgG antibodies to HSV-2. Test principle is identical to the predicate device.

    AI/ML Overview

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

    Device: Plexus™ HerpeSelect® HSV 1 and 2 IgG (with software)

    1. Table of Acceptance Criteria and Reported Device Performance

    The document doesn't explicitly state "acceptance criteria" in a quantitative manner for all performance aspects. However, the "Summary of Previous Studies for Plexus™ HerpeSelect® HSV 1 and 2 IgG (manual calculation)" table on page 2 provides clear performance metrics that can be interpreted as the device meeting expected performance for a similar predicate device.

    For the purpose of this analysis, I will synthesize "acceptance criteria" from the described study results, assuming that the reported performance met the internal and regulatory expectations for market clearance.

    Acceptance Criteria (Inferred from Study Results)Reported Device Performance (Plexus™ HerpeSelect® HSV 1 and 2 IgG)
    Agreement with Plexus Software vs. Manual Calculation
    HSV-1 Index Agreement100% (95% CI: 0.977 - 1.00) for HSV-1 Positives (n=161)
    100% (95% CI: 0.398 - 1.00) for HSV-1 Equivocal (n=4)
    100% (95% CI: 0.973 - 1.00) for HSV-1 Negatives (n=134)
    HSV-2 Index Agreement100% (95% CI: 0.974 - 1.00) for HSV-2 Positives (n=139)
    100% (95% CI: 0.590 - 1.00) for HSV-2 Equivocal (n=7)
    100% (95% CI: 0.976 - 1.00) for HSV-2 Negatives (n=153)
    Performance in Indicated Populations
    Pregnant Women HSV-1 Specificity96.5% (95%CI 92.5-98.7%)
    Pregnant Women HSV-1 Sensitivity92.2% (95%CI 86.1-96.2%)
    Pregnant Women HSV-2 Specificity94.3% (95%CI 88.5-97.7%)
    Pregnant Women HSV-2 Sensitivity95.5% (95%CI 91.2-98.0%)
    Sexually Active Adults HSV-1 Specificity91.0% (95%CI 85.4-95.0%)
    Sexually Active Adults HSV-1 Sensitivity96.5% (95%CI 92.0-98.9%)
    Sexually Active Adults HSV-2 Specificity96.3% (95%CI 90.9-99.0%)
    Sexually Active Adults HSV-2 Sensitivity97.4% (95%CI 93.9-99.1%)
    Agreement with CDC HSV/CMV Panel
    Agreement with HSV-1 Positives100% (54/54), 95%CI 89.1-100% (for HSV-1 Positive only), 95%CI 84.6-100% (for Dual Positive)
    Agreement with HSV-2 Positives100% (36/36), 95%CI 76.8-100% (for HSV-2 Positive only), 95%CI 84.6-100% (for Dual Positive)
    Agreement with Negatives100% (32/32), 95%CI 89.1-100% (for Dual Negative)
    Performance in Low Prevalence Population
    Low Prevalence HSV-1 Agreement with Negatives97.9% (46/47), 95%CI 88.7-99.9%
    Low Prevalence HSV-2 Agreement with Negatives100% (71/71), 95%CI 94.9-100%
    Cross-reactivity
    HSV-1 Cross-reactivity: CMV, EBV, VZV combined0-5% observed (e.g., 5.0% for CMV, 3.0% for VZV, 3.1% for EBV, for samples that were HSV-1 ELISA dual negative but positive for other viruses). Specifically, for dual negatives: One out of 37 samples was HSV-1 equivocal/positive, which was triple positive for CMV, VZV, EBV.
    HSV-2 Cross-reactivity: CMV, EBV, VZV combined0-3% observed (e.g., 0.0% for CMV, 2.9% for VZV, 3.2% for EBV, for samples that were HSV-2 ELISA dual negative but positive for other viruses). Specifically, for dual negatives: One out of 37 samples was HSV-2 equivocal/positive, which was positive for VZV and EBV.
    Reproducibility
    %CV of Positives (Inter/Intra-assay, Inter-Lab)≤10% for most positive samples, with some acceptable variations (e.g., Sample 9 HSV-1 Inter-assay %CV was 10.3%, Sample 3 HSV-1 Inter-assay %CV was 14.9%, HSV-2 Sample 3 Inter-assay %CV was 28.3%)
    Inter-Lot %CVGenerally
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