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510(k) Data Aggregation

    K Number
    K030124
    Device Name
    OLYMPUS FERRITIN REAGENT
    Manufacturer
    OLYMPUS AMERICA, INC.
    Date Cleared
    2003-02-06

    (23 days)

    Product Code
    DBF
    Regulation Number
    866.5340
    Type
    Special
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    OLYMPUS FERRITIN REAGENT

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

    Reagent for the determination of ferritin concentrations in human serum using the Olympus family of clinical chemistry analyzers. Serum ferritin is an indicator of body iron stores: it has been shown to correlate with stainable bonemarrow iron. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.

    Device Description

    Olympus Ferritin Reagent

    AI/ML Overview

    This document is a 510(k) premarket notification approval letter for the Olympus Ferritin Reagent. It does not contain information about acceptance criteria or a study proving that a device (in the sense of a diagnostic algorithm or imaging system) meets acceptance criteria.

    The document discusses a reagent used in a laboratory test for ferritin concentrations. The FDA's determination is based on the substantial equivalence of this reagent to a legally marketed predicate device, not on specific performance criteria demonstrated by a clinical study of an AI-powered device or imaging system.

    Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) because it is not present in the provided text.

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