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510(k) Data Aggregation

    K Number
    K082067
    Device Name
    MSC LIPID CONTROL
    Manufacturer
    MAINE STANDARDS CO.
    Date Cleared
    2008-08-22

    (31 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K012513
    Predicate For
    K103271
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MSC Lipid Control is intended for use as an assayed control material to monitor the ongoing precision of clinical laboratory analysis for Cholesterol, Triglycerides, HDL Cholesterol, and LDL Cholesterol. This material is intended for use on automated, semi-automated, and manual clinical chemistry analyzer systems.

    Device Description

    The MSC Lipid Control is a human serum based liquid control containing stabilized Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol of human origin.

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device called "MSC Lipid Control," which is a quality control material for clinical laboratory analysis of lipids. It does not contain any information regarding acceptance criteria, device performance, sample sizes for test or training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or the type of ground truth used for AI-driven devices.

    This document describes a traditional medical device (a control material) and its substantial equivalence to a predicate device, rather than a novel device requiring extensive performance studies with AI or human readers. Therefore, the requested information elements are not applicable to the provided context.

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