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510(k) Data Aggregation

    K Number
    K021671
    Device Name
    JAS HDL CHOLESTEROL (AUTOMATED) REAGENT
    Manufacturer
    JAS Diagnostics, Inc.
    Date Cleared
    2002-07-19

    (59 days)

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

    JAS HDL CHOLESTEROL (AUTOMATED) REAGENT

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

    Intended for the In Vitro, quantitative determination of HDL Cholesterol in human serum on automated chemistry analyzers.

    HDL Cholesterol measurements are used in the diagnosis and treatment of disorders involving low HDL Cholesterol, which is associated with an increased risk of coronary heart disease and coronary artery disease.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for an "HDL Cholesterol (Automated) REAGENT." This document primarily covers the regulatory approval of the device and does not contain the specific technical details about acceptance criteria or the study used to prove the device meets them.

    Therefore, I cannot provide the requested information based on the given input. The document is a regulatory approval letter, not a scientific study report or a detailed submission outlining performance characteristics.

    To answer your questions, I would need to analyze a different type of document, such as:

    • A summary of safety and effectiveness from the 510(k) submission.
    • The applicant's performance study report.
    • The labeling/instructions for use for the device, which often contains performance characteristics.
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