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510(k) Data Aggregation

    K Number
    K990207
    Device Name
    GLIADIN IGA ELISA TEST SYSTEM
    Manufacturer
    ZEUS SCIENTIFIC, INC.
    Date Cleared
    1999-03-26

    (64 days)

    Product Code
    MST
    Regulation Number
    866.5750
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Zeus Scientific, Inc. Gliadin IgA ELISA test system is intended for the qualitative and semi-quantitative detection of IgA-class antibodies to gliadin in human serum. The test system is intended to be used as an aid in the diagnosis of gastrointestinal disorders, mainly Coeliac Disease. This test is for in vitro diagnostic use.

    Device Description

    Gliadin IgA ELISA Test System

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) clearance letter from the FDA, which primarily states that the Gliadin IgA ELISA Test System is substantially equivalent to legally marketed predicate devices.

    The letter mentions:

    • Device Name: Gliadin IgA ELISA Test System
    • Intended Use: For the qualitative and semi-quantitative detection of IgA-class antibodies to gliadin in human serum, as an aid in the diagnosis of gastrointestinal disorders, mainly Coeliac Disease.
    • Regulatory Class: II

    However, it does not contain any details about:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes used, data provenance, or retrospective/prospective nature of a study.
    3. Number of experts, their qualifications, or how ground truth was established for a test set.
    4. Adjudication methods.
    5. Multi-reader multi-case (MRMC) comparative effectiveness study, or effect size of human improvement with AI.
    6. Standalone algorithm performance.
    7. Type of ground truth used (pathology, expert consensus, outcomes data).
    8. Sample size for the training set.
    9. How ground truth for the training set was established.

    This document serves as regulatory approval, not a scientific study report. To find the information requested, a different document, such as a summary of safety and effectiveness from the 510(k) submission, would be required.

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