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510(k) Data Aggregation

    K Number
    K061886
    Device Name
    ACTIM PROM AND CONTROLS
    Manufacturer
    MEDIX BIOCHEMICA
    Date Cleared
    2007-01-25

    (206 days)

    Product Code
    OAM, JJX
    Regulation Number
    862.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDIX BIOCHEMICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Actim PROM test is a visually interpreted, qualitative immunochromatographic rapid test for the detection of amniotic fluid in cervicovaginal secretions during pregnancy. Actim PROM test detects IGFBP-1, which is a major protein in amniotic fluid and a marker of the presence of amniotic fluid in a cervicovaginal sample. The test is intended for professional use to help diagnose the rupture of fetal membranes (ROM) in pregnant women at >34 weeks gestation when patients report signs, symptoms or complaints suggestive of ROM or if such signs are otherwise observed. The Actim PROM Controls are intended for use as external controls with the Actim PROM test. The controls may also be used to demonstrate negative results and weak and strong positive results.
    Device Description
    The Actim PROM is a rapid test for detection of premature rupture of fetal membranes. The test principle is lateral flow immunochromatography. Actim PROM is available in packages of 3, 10 and 20 tests. Each individual test pack contains a sterile polyester swab, specimen extraction solution and a dipstick. The dipstick is packed in a foil pouch with desiccant. The Actim PROM Controls contain one vial each of negative, low positive and high positive controls, and reconstitution solution.
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