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510(k) Data Aggregation

    K Number
    K191462
    Device Name
    Proov Test
    Manufacturer
    MFB Fertility, Inc.
    Date Cleared
    2020-02-27

    (269 days)

    Product Code
    QKE
    Regulation Number
    862.1620
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    Product Code :

    QKE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Proov test is intended for the detection of pregnanediol glucuronide (PdG, the major urine metabolite of progesterone) in urine and can be used as an aid for confirmation of ovulation.
    Device Description
    The Proov Test is intended for measuring pregnanediol glucuronide (PdG) in first morning urine during the luteal phase of the monthly female reproductive cvcle. The Proov Test is a disposable lateral flow test strip, consisting of a test area and control area. The urine sample is applied to the strip by dipping. The sample moves by lateral flow into the test area, and then the control area. The test area has PdG-specific reagents impregnated on it to detect the present of PdG in the urine. The control area has antibodies impregnated to be used as internal control for proper assay function. The test strip is intended for use outside the body (in vitro diagnostic use) and provides qualitative results with a single red line indicating a positive result for PdG and two red lines indicating a negative result for PdG in urine. Women can use Proov Test at multiple times during their menstrual cycle to confirm ovulation.
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