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510(k) Data Aggregation

    K Number
    K041016
    Device Name
    NOVA GLUCOSE LOW/HIGH LEVEL CONTROL SOLUTIONS
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Date Cleared
    2004-05-07

    (17 days)

    Product Code
    JJX
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NOVA GLUCOSE LOW/HIGH LEVEL CONTROL SOLUTIONS

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

    Nova Glucose Low/High Level Control Solutions are assayed quality control materials, which are used to verify the performance of BD Logic Blood Glucose Monitor, BD Latitude Diabetes Management System, BD/MiniMed Blood Glucose Monitor, and MiniMed Paradigm Link Blood Glucose Monitor. This control is an OTC product intended for use in the home setting.

    The Nova Glucose Low/High Level Control Solutions are for in vitro diagnostic use ONLY.

    Device Description

    Nova Glucose Low/High Level Control Solutions

    AI/ML Overview

    The provided documents do not contain information about acceptance criteria or a study proving that a device meets such criteria. The documents are a 510(k) premarket notification letter for "Nova Glucose Low/High Level Control Solutions" and its "Indications for Use" statement.

    Specifically, the letter is a determination by the FDA that the Nova Glucose Low/High Level Control Solutions are substantially equivalent to a legally marketed predicate device. This type of notification does not typically include detailed study results or acceptance criteria in the public release.

    Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from the provided text.

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