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510(k) Data Aggregation

    K Number
    K982341
    Device Name
    DIRECT HDL-CHOLESTROL LIQUID
    Manufacturer
    RANDOX LABORATORIES, LTD.
    Date Cleared
    1998-07-30

    (38 days)

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

    DIRECT HDL-CHOLESTROL LIQUID

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

    The Randox Liquid Direct HDL-Cholesterol (HDL-C) test kit is an in vitro diagnostic reagent for the quantitative determination of HDL-Cholesterol in human serum and plasma. Accurate measurement of HDL-C is of importance when assessing patient risk from coronary heart disease.

    In this diagnostic test kit a method for direct measurement of HDL-C, without sample pretreatment is presented.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for a "Direct HDL Cholesterol" device, informing the manufacturer that their device is substantially equivalent to legally marketed predicate devices.

    The letter discusses regulatory classifications, general controls, and compliance requirements, but it does not include:

    • A table of acceptance criteria and reported device performance.
    • Information about sample sizes, data provenance, number or qualifications of experts, or adjudication methods for ground truth establishment.
    • Details about multi-reader multi-case (MRMC) studies or standalone algorithm performance.
    • The type of ground truth used.
    • Sample size for the training set or how its ground truth was established.

    This document is a regulatory approval notice, not a scientific study report or performance evaluation.

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