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510(k) Data Aggregation

    K Number
    K110605
    Device Name
    ROM PLUS
    Manufacturer
    CLINICAL INNOVATIONS, LLC
    Date Cleared
    2011-11-23

    (266 days)

    Product Code
    NQM, JJX
    Regulation Number
    862.1550
    Why did this record match?
    Product Code :

    NQM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Clinical Innovations ROM Plus fetal membrane rupture test is a rapid, qualitative immunochromatographic test for the in vitro detection of amniotic fluid in vaginal secretions of pregnant women with signs and symptoms of ROM. The test detects AFP (alpha-fetoprotein) and PP12 (placental protein 12 or insulin growth factor binding protein) from amniotic fluid in vaginal secretion. The test is for prescription use by health care professionals to aid in the detection of rupture of membranes (ROM) in pregnant women in conjunction with other signs and symptoms. The ROM Plus Quality Control Kit monitors the performance of the ROM Plus Fetal Membranes Rupture Test for the purposes of external quality control. The lyophilized human positive protein control is an assayed control material for qualitative testing.
    Device Description
    The ROMPlus is a rapid test for detection of premature rupture of fetal membranes. The test principle is lateral flow immunochromatography. ROM Plus is available in packages of 5 tests. Each individual test pack contains a sterile polyester swab. specimen extraction buffer solution in a plastic vial and a cassette with integral timer containing the lateral flow strip packed in a foil pouch with desiccant. The ROM Plus Controls contain one vial each of negative, and positive controls, with integral reconstitution solution.
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    K Number
    K081767
    Device Name
    AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1
    Manufacturer
    AMNISURE INTERNATIONAL, LLC
    Date Cleared
    2009-01-09

    (203 days)

    Product Code
    NQM, NOM
    Regulation Number
    862.1550
    Why did this record match?
    Product Code :

    NQM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Amnisure® ROM (rupture of fetal membrane) Test is a rapid, non-instrumented, qualitative immunochromatographic test for the in vitro detection of ammiotic fluid in vaginal secretion of pregnant women. Amnisure® detects PAMG-1 protein marker of the amnictic fluid in vaginal secretions. The test is for use by health care professionals to aid in the detection of ROM when patients report signs, symptoms or complaints suggestive of ROM.
    Device Description
    The Amnisure® ROM (rupture of fetal membrane) Test is a rapid, non-instrumented, qualitative immunochromatographic test for the in vitro detection of ammiotic fluid in vaginal secretion of pregnant women. Amnisure® detects PAMG-1 protein marker of the amnictic fluid in vaginal secretions.
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