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510(k) Data Aggregation

    K Number
    K963645
    Device Name
    HERPES GROUP IGG ELISA TEST SYSTEM
    Manufacturer
    ARMKEL, LLC.
    Date Cleared
    1997-02-04

    (145 days)

    Product Code
    LGC
    Regulation Number
    866.3305
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HERPES GROUP IGG ELISA TEST SYSTEM

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

    The Herpes Group IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for qualitative determination of IgG antibodies in human serum to Herpes simplex virus. The Herpes Group IgG ELISA kit may be used to evaluate paired sera for the presence seroconversions of IgG as an aid in the diagnosis of Herpes simplex virus infection.

    Device Description

    The Herpes Group IgG ELISA test is an enzyme linked immunosorbent assay to detect IgG antibodies to Herpes simplex virus. Purified Herpes Group antigen is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.

    AI/ML Overview

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

    Acceptance Criteria and Device Performance

    Acceptance CriteriaReported Device Performance
    Relative Sensitivity (compared to Clark HSV 1 & HSV 2 ELISA)Overall: 98.9% (95% CI: 97.9% - 100%)
    Site 1: 99.1%
    Site 2: 97.9%
    Site 3: 99.1%
    Site 4: 100.0%
    Relative Specificity (compared to Clark HSV 1 & HSV 2 ELISA)Overall: 96.7% (95% CI: 94.2% - 99.1%)
    Site 1: 94.7%
    Site 2: 100%
    Site 3: 94.7%
    Site 4: 96.2%
    Relative Agreement (compared to Clark HSV 1 & HSV 2 ELISA)Overall: 98.1% (95% CI: 97.0% - 99.2%)
    Site 1: 97.2%
    Site 2: 98.6%
    Site 3: 97.7%
    Site 4: 98.9%
    Precision (Inter-site, %CV)**Generally
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