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    K Number
    K022333
    Device Name
    SPIFE LIPPOROTEIN-12, MODEL 3344
    Manufacturer
    HELENA LABORATORIES
    Date Cleared
    2002-08-15

    (28 days)

    Product Code
    JHO
    Regulation Number
    862.1475
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SPIFE LIPPOROTEIN-12, MODEL 3344

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

    The SPIFE Lipoprotein-12 System is intended for the separation and quantitation of serum or plasma lipoproteins used in the diagnosis and treatment of lipid disorders, atherosclerosis, and various liver and renal diseases.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "SPIFE Lipoprotein-12 System." This document does not contain the detailed information required to describe the acceptance criteria, study design, or performance metrics in the format requested.

    Specifically, it lacks:

    • A table of acceptance criteria and reported device performance.
    • Sample sizes for test sets, data provenance, or expert details for ground truth.
    • Information on adjudication methods, MRMC studies, or standalone algorithm performance.
    • Details on the type of ground truth used or the training set sample size and its ground truth establishment.

    The letter primarily confirms that the device is substantially equivalent to a predicate device and can be marketed, and it outlines the indications for use. It does not delve into the specifics of validation studies.

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