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510(k) Data Aggregation

    K Number
    K231465
    Device Name
    Q-Pad Test System
    Manufacturer
    Qurasense
    Date Cleared
    2023-12-06

    (201 days)

    Product Code
    LCP, QZG
    Regulation Number
    864.7470
    Why did this record match?
    Applicant Name (Manufacturer) :

    Qurasense

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The O-Pad Test System is comprised of the O-Pad Kit and the O-Pad A1c Test. The Q-Pad Kit is an in vitro diagnostic specimen collection and storage device intended for the collection of menstrual blood samples by individuals 18 years and older for subsequent analysis by an assay validated for use with the Q-Pad menstrual pad. The Q-Pad A1c Test is an in vitro diagnostic device for the quantitative measurement of Hemoglobin A1C using menstrual whole blood collected onto filter paper using the Q-Pad A1c Test is for the measurement of HbA I c on whole menstrual blood which will be self-collected by lay users at home and shipped to the laboratory by mail. Measurements obtained through this method can be used for monitoring the long-term control of blood sugar (glucose) in women with diabetes. This test is not to be used to diagnose or screen for diabetes.
    Device Description
    The Q-Pad Test System consists of the Q-Pad Kit and the Q-Pad A1c Test. The Q-Pad Kit is an in vitro diagnostic specimen collection and storage device intended for the collection of menstrual blood samples. The Q-Pad A1c Test is an in vitro diagnostic device for the quantitative measurement of Hemoglobin A1C using menstrual whole blood collected onto filter paper using the Q-Pad Kit. The Q-Pad menstrual pad (also referred to as "Q-Pad") is a modified menstrual pad which looks, feels, and is used like a normal menstrual pad. The Q-Pad has an embedded blood collection strip (Q-Strip) which can easily be removed and shipped for analysis at a laboratory. Instructions for use and results are presented in a HIPAA compliant mobile application.
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