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510(k) Data Aggregation

    K Number
    K040352
    Device Name
    NOVA-ONE LIPID CONTROL (SPECIAL LOW INTERFERENCE LIQUID LIPID CONTROL)
    Manufacturer
    BIORESOURCE TECHNOLOGY, INC.
    Date Cleared
    2004-04-02

    (50 days)

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

    NOVA-ONE LIPID CONTROL (SPECIAL LOW INTERFERENCE LIQUID LIPID CONTROL)

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

    NOVA-ONE Control is intended for use in the laboratory to monitor the accuracy and rrovit one of the listed constituents. The routine use of quality control materials is an integral part of evaluating the accuracy and precision of laboratory analysis.

    Device Description

    NOVA-ONE Lipid Control Human Liquid Lipid Control

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for a quality control material (NOVA-ONE Lipid Control Human Liquid Lipid Control). It does not contain information about acceptance criteria or a study proving device performance as typically expected for medical AI/imaging devices.

    Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies because the provided text does not contain this type of data. The letter simply states that the device is substantially equivalent to legally marketed predicate devices, which is a regulatory determination for a quality control material and not a performance study as described in your request.

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