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510(k) Data Aggregation

    K Number
    K013323
    Device Name
    TCI-31 LIFELONG OVULATION TESTER
    Manufacturer
    TCI NEW YORK
    Date Cleared
    2001-12-05

    (61 days)

    Product Code
    CEP
    Regulation Number
    862.1485
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    Applicant Name (Manufacturer) :

    TCI NEW YORK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ovulation Tester is an over-the-counter device intended to detect the most fertile days of a woman's menstrual cycle by the direct visualization of the characteristic peri-ovulatory ferning pattern seen in dried saliva. This ferning occurs due to increased levels of estrogen.
    Device Description
    The Ovulation Tester is a complete system for identifying the most fertile day(s) of a woman's menstrual cycle using a direct saliva sample. These fertile days are detected through the observation of distinctive crystallization or ferning patterns seen on a glass slide. The test is selfadministered and is completely portable. The system requires no reagents nor specific storage conditions, can be performed with relative ease, and results may be interpreted within approximately 10 minutes of saliva application. The test is intended for over-the-counter (OTC) use. The Ovulation Tester Kit consists of: 1. the Ovulation Tester device (see below for further details) with tracking disk 2. an extra tracking disk 3. the saliva brush applicator 4. the Instruction Booklet 5. a marking pencil 6. the storage bag The Ovulation Tester device consists of 1. the black microscope eyepiece 2. the rubber eve cup (shown installed over the black eyepiece) 3. the tracking disk (stored in the unit) 4. the battery (already in place) 5. the light source (already in place) The Ovulation Tester is a hand-held, circular shaped "minimicroscope" containing four sets of five miniaturized microscope slides in a plastic case. The slides are made from optical glass, and are placed on a round tracking disk; the disk serves as the platform for viewing the dried saliva patterns. One tracking disk may be used for several months. The device also includes a small built-in light (light emitting diode [LED]) as its light source for viewing the slides, a replaceable battery (1.5 volt) and electronic circuitry. The system is designed to perform sequential testing over five consecutive days; the testing days are based on the woman's expected cycle length. To perform the test, a woman places a thin coat of saliva on a slide by means of the saliva brush applicator. After the saliva has been allowed to air-dry, the tracking disk is rotated so that the day-specific slide lines up at the proper opening. The device is brought in close proximity to the viewing eye, and a black button on the back of the device is pushed: this activates the green light to allow viewing of the dried saliva patterns. The preovulatory days are characterized by ferning patterns, while, on other days, the slides will appear with "debris-like" substances such as dots, circles, or cells.
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