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510(k) Data Aggregation

    K Number
    K053157
    Manufacturer
    Date Cleared
    2005-12-09

    (25 days)

    Product Code
    Regulation Number
    862.1475
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A

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

    The AHDL method for the Dimension® clinical chemistry system is an in vitro diagnostic device intended to quantitatively measure high density lipoprotein cholesterol (HDL-C) in human serum and plasma. HDL-C measurements are used as an aid in the diagnostics of lipid disorders.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for the Dimension® Automated HDL Cholesterol (AHDL) device, indicating substantial equivalence to predicate devices. It does not contain a detailed study report with specific acceptance criteria or reported device performance metrics in the format requested.

    The letter confirms the device is an in vitro diagnostic intended to quantitatively measure high-density lipoprotein cholesterol (HDL-C) in human serum and plasma, used as an aid in the diagnostics of lipid disorders.

    Therefore, I cannot extract the following information from the provided text:

    • A table of acceptance criteria and the reported device performance
    • Sample size used for the test set and the data provenance
    • Number of experts used to establish the ground truth for the test set and the qualifications of those experts
    • Adjudication method for the test set
    • If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
    • If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
    • The type of ground truth used
    • The sample size for the training set
    • How the ground truth for the training set was established

    This letter represents the FDA's decision regarding the device's clearance, not the detailed study results that led to that decision. Such information would typically be found in the manufacturer's 510(k) submission itself.

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