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510(k) Data Aggregation

    K Number
    K973040
    Device Name
    SPIFE IFE-6
    Manufacturer
    HELENA LABORATORIES
    Date Cleared
    1998-01-02

    (141 days)

    Product Code
    CFF
    Regulation Number
    866.5510
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This kit is intended for the separation of immunoglobulins in serum using agarose gel electrophoresis.

    This kit could be useful in the diagnosis of various disease states which typically exhibit abnormal patterns. Examples of such gammopathies are multiple myeloma, collagen disorders and other chronic infections.

    Device Description

    Not Found

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA for the device "SPIFE IFE-6," indicating that it has been found substantially equivalent to a legally marketed predicate device.

    Therefore, I cannot extract the requested information regarding:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size used for the test set or data provenance.
    3. Number of experts or their qualifications for ground truth.
    4. Adjudication method for the test set.
    5. MRMC comparative effectiveness study results.
    6. Standalone algorithm performance.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.
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