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510(k) Data Aggregation

    K Number
    K071510
    Device Name
    HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950
    Manufacturer
    FOCUS DIAGNOSTICS, INC.
    Date Cleared
    2007-09-24

    (112 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

    HerpeSelect® Express is a rapid test intended for qualitatively detecting the presence or absence of human IgG class antibodies to herpes simplex virus type 2 (HSV-2) in human whole blood (venous or capillary) or serum. The test is indicated for testing sexually active adults or pregnant women to aid in the presumptive diagnosis of HSV-2 infection.

    The HerpeSelect® Express IgG device has not been established for use in the pediatrics population, for neonatal screening, or for testing immunocompromised patients. This kit is not intended for self-testing, and this test is neither FDA cleared nor approved for testing blood or plasma donors.

    Device Description

    Rapid Lateral Flow assay for the qualitative detection of human IgG class antibodies to HSV-2

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the HerpeSelect Express IgG device, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are implied by the performance characteristics presented in comparison to the predicate device (HerpeSelect 1 and 2 Immunoblot IgG). The document does not explicitly state a pre-defined numerical "acceptance criteria" for sensitivity and specificity. Instead, it presents the device's performance, indicating that these achieved results were deemed acceptable for market clearance.

    Study Population & Sample TypeCriteriaAcceptance Criteria (Implied)Reported Device Performance (HerpeSelect Express vs. Immunoblot)
    Pregnant Women
    SeraSpecificityNot explicitly stated92.3% (108/117)
    SensitivityNot explicitly stated96.1% (271/282)
    Venous Whole BloodSpecificityNot explicitly stated93.2% (109/117)
    SensitivityNot explicitly stated97.2% (274/282)
    Capillary Whole BloodSpecificityNot explicitly stated94.9% (111/117)
    SensitivityNot explicitly stated95.4% (269/282)
    Sexually Active Adults
    SeraSpecificityNot explicitly stated92.9% (210/226)
    SensitivityNot explicitly stated91.8% (315/343)
    Venous Whole BloodSpecificityNot explicitly stated93.4% (211/226)
    SensitivityNot explicitly stated92.4% (317/343)
    Capillary Whole BloodSpecificityNot explicitly stated93.8% (212/226)
    SensitivityNot explicitly stated91.8% (315/343)
    Non-Sexually Active Adults (Low Prevalence)
    SeraSpecificityNot explicitly stated0% (0/2) * (This low sensitivity for positives with few samples is noted to indicate low prevalence)*
    SensitivityNot explicitly stated100% (101/101)
    Venous Whole BloodSpecificityNot explicitly stated0% (0/2)
    SensitivityNot explicitly stated100% (101/101)
    Capillary Whole BloodSpecificityNot explicitly stated0% (0/2)
    SensitivityNot explicitly stated100% (101/101)
    CDC HSV/CMV Panel
    SpecificityNot explicitly stated100% (35/35)
    SensitivityNot explicitly stated98.5% (64/65)
    Cross-reactivityOverall Cross-reactivityNot explicitly stated4.2% (9/213)
    Inter-Lot Reproducibility%CVNot explicitly stated
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