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510(k) Data Aggregation

    K Number
    K033433
    Device Name
    NOVA GLUCOSE CONTROL SOLUTIONS
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Date Cleared
    2004-01-02

    (66 days)

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

    The Nova Glucose Control Solution assayed quality control material is used to verify the performance of BD Glucose Monitoring Systems and the BD/Medtronic MiniMed Blood Glucose Monitoring Systems. This control is an OTC product intended for use in the home setting. The Nova Glucose Control Solutions are for in vitro diagnostic use ONLY.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for the Nova Glucose Control Solution. It describes the device, its intended use, and states that it has been found substantially equivalent to predicate devices. However, it does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria, as it is a regulatory clearance document, not a scientific study report.

    Therefore, I cannot extract the detailed information requested in the prompt based on the provided text. The document refers to "performance" in the "Indications for Use" section (to "verify the performance of BD Glucose Monitoring Systems"), but it does not define specific performance metrics, acceptance criteria, or present a study comparing these criteria to the device's actual performance.

    The questions below cannot be answered from the provided text:

    1. A table of acceptance criteria and the reported device performance: Not available.
    2. Sample size used for the test set and the data provenance: Not available.
    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
    4. Adjudication method: Not available.
    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not available.
    6. If a standalone performance (algorithm only) was done: Not applicable, as this is a control solution, not an algorithm.
    7. The type of ground truth used: Not available.
    8. The sample size for the training set: Not applicable, as this is a control solution, not a machine learning algorithm.
    9. How the ground truth for the training set was established: Not applicable.
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