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510(k) Data Aggregation

    K Number
    K192369
    Device Name
    PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
    Manufacturer
    iXensor Co. Ltd.
    Date Cleared
    2019-10-29

    (60 days)

    Product Code
    LCP
    Regulation Number
    864.7470
    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 PixoTest POCT System, consisting of PixoTest POCT Analyzer and PixoTest A1c Test Kit, is used for the quantitative measurement of glycated hemoglobin (%HbA1c) in fingerstick capillary and venous whole blood samples. It is an in-vitro diagnostic system intended to monitor long term glycemic control in individuals previously diagnosed with diabetes mellitus.

    The PixoTest POCT System is intended for clinical laboratory and Point-of-Care Professional use. It is not intended for use in the diagnosis of or screening for diabetes and is not intended for use on neonates.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the PixoTest POCT System for measuring glycated hemoglobin (HbA1c). However, it does not contain the specific acceptance criteria, detailed study results, or information about the sample size, ground truth establishment, expert qualifications, or adjudication methods for the performance studies.

    The letter confirms the device's clearance and its intended use: "quantitative measurement of glycated hemoglobin (%HbA1c) in fingerstick capillary and venous whole blood samples... intended to monitor long term glycemic control in individuals previously diagnosed with diabetes mellitus."

    To provide the requested information, you would need access to the full 510(k) premarket notification submission (K192369) itself, which typically includes detailed performance data from validation studies. This clearance letter only states that the device is "substantially equivalent" to legally marketed predicate devices, implying that its performance meets established standards, but does not explicitly list those standards or the specific data showing compliance.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them from the provided text. The document refers to the "enclosure" for the indications for use but does not include the detailed performance data that would answer your questions.

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