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    K Number
    K013213
    Device Name
    HYPERION VISIQUANT ANA TEST KIT
    Manufacturer
    HYPERION, INC.
    Date Cleared
    2002-06-04

    (251 days)

    Product Code
    DHN
    Regulation Number
    866.5100
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    K872845
    Why did this record match?
    Reference Devices :

    K872845

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

    The Hyperion VisiQuant™ ANA Test Kit is intended for the visual determination of anti-nuclear antibodies (ANA's) immunofluorescence pattern(s) and the semiquantitative measurement of ANA's in human serum with a single dilution as an aid in the invitro diagnosis of auto-immune and connective tissue diseases such as systemic lupus erythematosus (SLE) and Sjogren Syndrome.

    Device Description

    VisiQuant™ ANA is a unique ANA IFA. The test samples are assayed with a single dilution as in the traditional qualitative procedure to determine positive and pattern while obtaining a VisiQuant titer from the same image. The stained slides are read objectively with a digital camera through the FAN microscope to measure the fluorescence intensity of reacted substrate (Hip-2 calls). The Visiguant tive of the test sample is interpolated from a standard curve. VisiQuant ANA uses a unique fluorophore, La Jolla Blue (LJB), which has a longer fluorescence life (photostability) than fluorescent. LJJP has nearinfrared peak excitation and emission wavelengths to minimize autofluoresconce commonly present in biological substances.

    AI/ML Overview

    The Hyperion VisiQuant™ ANA Test Kit is intended for the visual determination of anti-nuclear antibodies (ANA's) immunofluorescence pattern(s) and the semiquantitative measurement of ANA's in human serum with a single dilution as an aid in the in-vitro diagnosis of auto-immune and connective tissue diseases such as systemic lupus erythematosus (SLE) and Sjogren Syndrome.

    1. Table of acceptance criteria and the reported device performance:

    Agreement in Test Results (Qualitative)

    CriteriaAcceptance Criteria (Implicit)Reported Device Performance
    Agreement for negative resultsHigh agreement, similar to predicate device98.92 %
    Agreement for positive resultsHigh agreement, similar to predicate device94.12 %

    Pattern Agreement (for positive samples)

    CriteriaAcceptance Criteria (Implicit)Reported Device Performance
    Pattern agreement (both positive, VisiQuant pattern matches Bion pattern)High agreement, similar to predicate device94.79 %
    Pattern agreement (Bion positive, VisiQuant pattern matches Bion pattern)High agreement, similar to predicate device89.21 %

    Quantitative Correlation (VisiQuant Titer vs. Bion IFA Titer)

    CriteriaAcceptance Criteria (Implicit)Reported Device Performance (R-value)
    Correlation for all positive patternsStrong positive correlation0.731 (N=96, p
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