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510(k) Data Aggregation

    K Number
    K040918
    Device Name
    WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2
    Manufacturer
    WAKO CHEMICALS, USA, INC.
    Date Cleared
    2004-05-17

    (39 days)

    Product Code
    JJX
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2

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

    The Wako Quality Control is intended for use as an assay quality maroations in of ooo. The transecision of laboratory testing procedures for the Wako Control scrain to monitor the processor of L-Cholesterol, LDL-Cholesterol, lipid assuy cash as Thigyonins, NEFA C, Free Cholesterol and beta Lipoprotein assays.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a study proving a device meets them.

    The document is a 510(k) clearance letter from the FDA for a device called "Wako Lipid Control." This letter states that the device is substantially equivalent to legally marketed predicate devices. While it mentions the device's "Indications for Use" (as a quality control material for lipid assays), it does not include any acceptance criteria or details of a study that proves the device meets specific acceptance criteria.

    The document is a regulatory approval, not a scientific study report.

    Therefore, I cannot populate the table or answer the specific questions about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details.

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