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    K Number
    K030849
    Device Name
    AMNISURE FETAL MEMBRANES RUPTURE TEST MODEL FMRT1
    Manufacturer
    N-DIA, INC.
    Date Cleared
    2004-02-02

    (322 days)

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

    N-DIA, INC.

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

    The AmniSure™ ROM (Rupture Of [fetal] Membranes) Test is a rapid, noninstrumented, qualitative immunochromatographic test for the in vitro detection of amniotic fluid in vaginal secretions of pregnant women. AmniSure detects PAMG-1 protein marker of the amniotic fluid in vaginal secretions. The test is for use by health care professionals to aid in the detection of ROM in pregnant women at > 34 weeks gestation when patients report signs, symptoms or complaints suggestive of ROM.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) Premarket Notification from the FDA for a device called "AmniSure™ ROM (Rupture of [fetal] Membranes) Test". While it outlines the device's intended use and FDA approval, it does not contain any information regarding acceptance criteria, study details, performance data, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria using only the information provided. The document primarily focuses on the regulatory approval process and states that the device is substantially equivalent to legally marketed predicate devices.

    To answer your questions, I would need access to the actual study report or the detailed premarket notification submission that would contain such information.

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