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510(k) Data Aggregation

    K Number
    K061841
    Device Name
    QUANTA LITE INTRINSIC FACTOR ELISA
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    2006-12-22

    (176 days)

    Product Code
    LIG
    Regulation Number
    862.1810
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    QUANTA LITE INTRINSIC FACTOR ELISA

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

    The QUANTA Lite™ Intrinsic factor ELISA is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of Intrinsic factor antibodies in human serum. The presence of Intrinsic factor antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of pernicious anemia.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification approval letter for the "QUANTA Lite™ Intrinsic Factor ELISA" device. It does not contain information about acceptance criteria, a specific study, or detailed performance metrics. The document only specifies the device name, its indications for use, and confirms its substantial equivalence to a legally marketed predicate device.

    Therefore, I cannot provide the requested information from this document. It lacks data on:

    1. Acceptance criteria and reported device performance: No such table is present.
    2. Sample size and data provenance: Not mentioned.
    3. Number and qualifications of experts for ground truth: Not mentioned.
    4. Adjudication method for the test set: Not mentioned.
    5. MRMC comparative effectiveness study or effect size: Not applicable as this is an in-vitro diagnostic test, not an AI-assisted imaging device.
    6. Standalone performance (algorithm only): Not applicable as this is an ELISA kit.
    7. Type of ground truth used: Not specified.
    8. Sample size for the training set: Not mentioned.
    9. How ground truth for the training set was established: Not mentioned.
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