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510(k) Data Aggregation

    K Number
    K012449
    Device Name
    DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM
    Manufacturer
    DIAMEDIX CORP.
    Date Cleared
    2001-10-26

    (86 days)

    Product Code
    MID
    Regulation Number
    866.5660
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM

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

    The Diamedix Is anti-Cardiolipin IgG/IgM Test Kit is an indirect enzyme immunoassay (EIA) for the semi-quantitative measurement of IgG or IgM antibodies to cardiolipin in human serum as an aid in the assessment of the risk of thrombosis in patient with SLE or SLE-like disorders. The assay can be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor.

    Device Description

    The Is anti-Cardiolipin IgG/IgM Test System is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative measurement of IgG or IgM antibodies to cardiolipin in human serum

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study details for the Diamedix Is-anti-Cardiolipin IgG/IgM Test System, based on the provided 510(k) summary:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly state pre-defined quantitative acceptance criteria with specific numerical targets. Instead, it describes performance characteristics and then presents the results. The implicit acceptance criteria are that the device demonstrates comparable performance to a commercially available predicate device and satisfactory analytical and clinical performance.

    Performance MetricIndication of Acceptance Criteria (Implicit)Reported Device Performance
    Calibration Equivalence3-point vs. 6-point calibration should show strong correlation.IgG: Y = 2.4036 + 0.9996X (r = 0.9861, n=172). IgM: Y = 0.5333 + 0.9411X (r = 0.9925, n=162). (Strong linear correlation demonstrated for both.)
    Relative Sensitivity (IgG)Should be comparable to commercially available ELISA kit.91.5% (95% CI: 79.6-97.6%)
    Relative Specificity (IgG)Should be comparable to commercially available ELISA kit.100.0% (95% CI: 96.6-100.0%)
    Overall Agreement (IgG)Should be comparable to commercially available ELISA kit.97.4% (95% CI: 93.5-99.3%)
    Relative Sensitivity (IgM)Should be comparable to commercially available ELISA kit.78.4% (95% CI: 67.3-87.1%)
    Relative Specificity (IgM)Should be comparable to commercially available ELISA kit.100.0% (95% CI: 95.8-100.0%)
    Overall Agreement (IgM)Should be comparable to commercially available ELISA kit.90.1% (95% CI: 84.4-94.2%)
    Clinical Specificity (IgG)High specificity in normal population, acceptable specificity in other autoimmune diseases.Normals: 99.5% (213/214), RPR Positive: 73.3% (11/15)
    Clinical Specificity (IgM)High specificity in normal population, acceptable specificity in other autoimmune diseases.Normals: 98.5% (211/214), RPR Positive: 73.3% (11/15)
    Clinical Sensitivity (IgG)Detectable in patients with APS and SLE.APS: 82.5% (47/57), SLE: 21.2% (7/33), Other Autoimmune Diseases: 8.6% (3/35)
    Clinical Sensitivity (IgM)Detectable in patients with APS and SLE.APS: 47.4% (27/57), SLE: 21.2% (7/33), Other Autoimmune Diseases: 14.2% (5/35)
    Cross ReactivityShould show minimal cross-reactivity with other common autoantibodies.Out of 36 samples tested (SSA/SSB, Scl-70, Jo-1, dsDNA, RF), one sample positive for dsDNA showed a positive result. The remaining 34 samples were negative. (Suggests minimal cross-reactivity with most, but potential with dsDNA.)
    Linearity (IgG)Demonstrates a linear response over a range of concentrations.Y = -4.9960 + 147.5101 X (r = 0.9957, R² = 0.9915).
    Linearity (IgM)Demonstrates a linear response over a range of concentrations.Y = 4.0837 + 87.9931 X (r = 0.9849, R² = 0.9701).
    Manual vs. Automated (IgG)Manual and MAGO Plus methods should show strong correlation.Y = 1.1058 + 1.1976 X (r = 0.9883, n=172). 6-point (automated vs. manual): (automated) = 1.0696 (manual) + 4.0821; 95% CI slope [1.0174 to 1.1218], intercept [1.3042 to 6.8600]. (Strong linear correlation demonstrated.)
    Manual vs. Automated (IgM)Manual and MAGO Plus methods should show strong correlation.Y = 1.3732 + 1.1510 X (r = 0.9917, n=162). 6-point (automated vs. manual): (automated) = 1.0169 (manual) + 2.2121; r=0.9772; 95% CI slope [0.9824 to 1.0514], intercept [1.1343 to 3.2899]. (Strong linear correlation demonstrated.)
    Precision (CV%)Coefficients of Variation (CV%) for intra-assay and interassay should be within acceptable limits (typically
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