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510(k) Data Aggregation

    K Number
    K091520
    Device Name
    IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA
    Manufacturer
    IMMCO DIAGNOSTICS, INC.
    Date Cleared
    2010-03-10

    (292 days)

    Product Code
    MVM
    Regulation Number
    866.5660
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Enzyme linked immunoassays (ELISA) for the qualitative and semiquantitative detection of anti-human Tissue Transglutaminase IgA or IgG antibodies in human serum to aid in the diagnosis of gluten sensitive enteropathy / celiac disease (CD) in conjunction with other laboratory and clinical findinas.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a cover letter from the FDA regarding a 510(k) premarket notification for an in vitro diagnostic device (ImmuLisa Celiac TtG rHuman Tissue Transglutaminase Antibody ELISAs).

    While it mentions the device, its intended use, and substantial equivalence to a predicate device, it does NOT contain any information about:

    1. Acceptance criteria or reported device performance.
    2. Sample sizes or data provenance for a test set.
    3. Number or qualifications of experts for ground truth establishment.
    4. Adjudication method.
    5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
    6. Standalone algorithm performance.
    7. Type of ground truth used (e.g., pathology, outcomes data).
    8. Sample size for the training set.
    9. How ground truth for the training set was established.

    This document is a regulatory approval letter, not a scientific study report or a summary of performance data. Therefore, I cannot extract the requested information from the provided text.

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