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510(k) Data Aggregation

    K Number
    K012795
    Device Name
    DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM
    Manufacturer
    DIAMEDIX CORP.
    Date Cleared
    2001-09-28

    (38 days)

    Product Code
    MST
    Regulation Number
    866.5750
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM

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

    The Diamedix Is anti-Gliadin IgG Test Kit is an indirect enzyme immunoassay (EIA) for the semi-quantitative measurement of IgG antibodies to gliadin in human serum as an aid in the diagnosis of celiac disease. These reagents can be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor.

    Device Description

    The Is-anti-Gliadin IgG Test System is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative measurement of IgG antibodies to gliadin in human serum.

    AI/ML Overview

    Here's an analysis of the provided 510(k) summary, extracting the requested information about acceptance criteria and the study that proves the device meets them:

    1. Table of Acceptance Criteria and Reported Device Performance

    The 510(k) summary does not explicitly state pre-defined "acceptance criteria" in a quantitative format (e.g., "sensitivity must be >X%"). Instead, it presents performance characteristics and implies that these results are deemed acceptable for substantial equivalence to the predicate device and for the intended use.

    Based on the provided data, we can infer the following performance metrics:

    Performance MetricAcceptance Criteria (Implied)Reported Device Performance
    Relative Sensitivity (vs. other EIA)Should be comparable to or better than predicate device. (No explicit threshold stated.)87.5% (95% CI: 79.2-93.4%)
    Relative Specificity (vs. other EIA)Should be comparable to or better than predicate device. (No explicit threshold stated.)100.0% (95% CI: 95.8-100.0%)
    Overall Agreement (vs. other EIA)Should be comparable to or better than predicate device. (No explicit threshold stated.)93.4% (95% CI: 88.8-96.6%)
    Clinical Specificity (Normals)High specificity in healthy population. (No explicit threshold stated.)97.1% (203/209)
    Clinical Specificity (Other Diseases)High specificity in other disease populations to minimize cross-reactivity. (No explicit threshold stated.)96.2% (128/133)
    Clinical Sensitivity (Possible Celiac Disease)High sensitivity in suspected celiac disease. (No explicit threshold stated.)94.4% (68/72)
    Clinical Sensitivity (Diagnosed Celiac Disease)High sensitivity in confirmed celiac disease. (No explicit threshold stated.)75.0% (42/56)
    Correlation (Manual vs. Automated)Strong positive correlation (e.g., r > 0.9).Correlation Coefficient (r) = 0.9577
    Precision (Intra-assay & Interassay)Low variability (e.g., CV%
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