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    K Number
    K013582
    Device Name
    MAYBE?MOM MINI OVULATION MICROSCOPE
    Manufacturer
    MAYBE?MOM
    Date Cleared
    2003-01-16

    (443 days)

    Product Code
    CEP
    Regulation Number
    862.1485
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Maybe MOM® Mini Ovulation Microscope is intended to be used only to indicate when a woman is ovulating by visualizing a woman's dried saliva on a lens. When a woman is ovulating, the increased secretion of estrogen is associated with a fern-like dried salivary pattern.
    Device Description
    The MAYBE? MOM® Mini Ovulation Microscope identifies the most fertile day(s) of a woman's menstrual cycle using a direct saliva sample. The fertile day(s) are detected through the observation of distinctive crystallization or ferning patterns seen on a glass slide. The test is self-administered and is completely portable. It requires no reagents nor specific storage conditions and the testing can be performed with relative ease. The results may be interpreted as soon as saliva applied to the slide dries, usually within 2-6 minutes. The MAYBE? MOM® Mini Ovulation Microscope is to be marketed for over-the-counter (OTC) use. The MAYBE? MOM® Mini Ovulation Microscope consists of: - a black microscope eyepiece with a microscope slide . - a rubber eye cup . - a plastic cylindrical body . - a battery . - a light source. . All of these parts are in place in the unit. The consumer does not do anything to the Mini Ovulation Microscope except to place a drop of saliva on the microscope eyepiece/slide, press the light source to illuminate the salivary feming pattern and focus the microscope to obtain the best view. The Mini Ovulation Microscope is a hand-held, circular shaped mini microscope containing a miniaturized focusing lens and a miniaturized slide. The slide serves as the platform upon which the saliva is placed and for viewing the dried saliva pattern. The device also includes a miniaturized light source (light emitting diode - LED) that serves as the light source and electronic circuitry. The battery is operated with a replaceable 1.5-volt battery. The Mini Ovulation Microscope is completely reusable, and requires only the cleaning of the mini microscope slide to be reused. The Mini Ovulation Microscope is designed to be used throughout the menstrual cycle. To perform the test, a small drop of saliva is placed on the slide. After the saliva air-dries (usually in 2-6 minutes), the eve piece is brought to close proximity to the eye for viewing. The black button on the bottom of the Mini Ovulation Microscope is pressed to activate the vellow light that allows viewing of the dried saliva pattern. The non-ovulatory (non-fertile) days are identified by "debris-like" substances, such as dots, circles, or random cells. Ovulatory days are characterized by distinct ferning patterns. Days when some ferning and some random "debris-like" patterns are seen are peri-ovulatory days during which some chance of pregnancy exists.
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    K Number
    K022829
    Device Name
    INSTANT-VIEW LH OVULATION PREDICTING TEST
    Manufacturer
    ALFA SCIENTIFIC DESIGNS, INC.
    Date Cleared
    2002-11-05

    (71 days)

    Product Code
    CEP
    Regulation Number
    862.1485
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Instant-View™ LH Ovulation Predicting Test is a qualitative immunoassay for the detection of human Luteinizing Hormone (hLH) in human urine to predict the occurrence of ovulation. This device is intended for professional and laboratory use only. The Instant-View™ LH Ovulation Predicting Test is a qualitative immunoassay for the detection of human Luteinizing Hormone (hLH) in human urine to predict the occurrence of ovulation. It is for health care professional use, including at the point of care (physician's office labs, doctor's offices).
    Device Description
    This test is a one-step lateral flow chromatographic immunoassay. Instant-View™ LH Ovulation Predicting Test has two formats, cassette test and dip-strip test. The cassette test contains the dip-strip in a plastic housing.
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    K Number
    K021409
    Device Name
    AT HOME OVULATION TEST, MODEL 9032
    Manufacturer
    PHAMATECH INC.
    Date Cleared
    2002-05-24

    (21 days)

    Product Code
    CEP
    Regulation Number
    862.1485
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Phamatech At Home Ovulation Test is a rapid qualitative test for the detection of luteinizing hormone (LH) in urine. The cut-off concentration for this test is as follows: LH at 30mlU/mL. This assay is intended for use in the home to assist in determining the ovulation cycle. The Phamatech At Home Ovulation Test is intended for over the counter use.
    Device Description
    Immunoassay for the qualitative detection of LH in urine. The At HOME OVULATION TEST, like many commercially available ovulation test kits, qualitatively measures the presence of luteinizing hormone by visual color sandwich one step immunoassay technology. All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / LH / colored (labeled) antibody complexes.
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    K Number
    K013874
    Device Name
    CLEARPLANE EASY OVULATION TEST
    Manufacturer
    UNIPATH LTD.
    Date Cleared
    2002-02-19

    (90 days)

    Product Code
    CEP
    Regulation Number
    862.1485
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CLEARPLAN EASY Ovulation Test, an over-the-counter (OTC) in vitro diagnostic device, is a urine test for the detection of luteinizing hormone. It is intended to be used by women as an aid to conception by accurately and reliably predicting ovulation.
    Device Description
    Not Found
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    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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    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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    K Number
    K012252
    Device Name
    QUIK-CHECK OVULATION PREDICTOR
    Manufacturer
    ACON LABORATORIES, INC.
    Date Cleared
    2001-08-24

    (37 days)

    Product Code
    CEP
    Regulation Number
    862.1485
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The QUIK-CHECK™ Ovulation Predictor Test is a qualitative, one-step, midstream assay for the detection of human Luteinizing Hormone (LH) in urine as an aid in conception by reliably predicting ovulation. The QUIK-CHECK™ Ovulation Predictor Test is intended for use by the lay consumer.
    Device Description
    The QUIK-CHECK™ Ovulation Predictor Test is a midstream test used for the qualitative measurement of Luteinizing Hormone (LH) and the detection of the LH surge in a woman's urine as an aid in reliably predicting ovulation. The ovulation predictor test is intended for use outside the body (in vitro diagnostic use) by women at home. The QUIK-CHECK™ ass outside the counter (OTC) device that will be sold under that will be sold under the QUIK-CHECK™ brand and various private labels. The QUIK-CHECK™ Ovulation Predictor Test employs a unique combination of monoclonal antibody-dye particle conjugates and polyclonal-solid phase antibodies to selectively identify human Luteinizing Hormone (LH) in urine. As the urine flows through the absorbent portion of the device, the antibody-dye particle conjugate binds to the LH, forming an antibodyantigen complex. This complex binds to the anti-LH antibody in the test zone and produces a pink-rose color band. The color intensity of this band is equal to or greater than that of the control band when the LH concentration is greater than 40 mIU/mL. In urine with LH concentrations of less than 40 mIU/mL, the band in the test zone will appear lighter than the control band. In the absence of LH in urine, no test band will show up in the test zone. The test has also incorporated a control system where a pink-colored band will always appear in the control zone, demonstrating that the test is functioning correctly.
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    K Number
    K991386
    Device Name
    EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK)
    Manufacturer
    SELFCARE, INC.
    Date Cleared
    1999-05-25

    (34 days)

    Product Code
    CEP
    Regulation Number
    862.1485
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ovulation Predictor test is used for the qualitative measurement of LH and the detection of LH surge in a woman's urine as an aid in conception by accurately and reliably predicting ovulation. The Ovulation Predictor test is intended for use outside the body (in vitro diagnostic use) by women at home. The Ovulation Predictor test is an over the counter (OTC) device that will be sold under the name Inverness Medical Early Ovulation Predictor, an under various private labels as One Step Ovulation Predictor or Ovulation Predictor.
    Device Description
    The Ovulation Predictor test is used for the qualitative measurement of LH and the detection of LH surge in a woman's urine as an aid in conception by accurately and reliably predicting ovulation. The Ovulation Predictor test is intended for use outside the body (in vitro diagnostic use) by women at home. The Ovulation Predictor test is an over the counter (OTC) device that will be sold under the name Inverness Medical Early Ovulation Predictor, an under various private labels as One Step Ovulation Predictor or Ovulation Predictor. The technological characteristics are the same because both devices are One-step urine tests that measure LH immunochromatographically, and have the same safety and effectiveness.
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    K Number
    K991466
    Device Name
    EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE)
    Manufacturer
    SELFCARE, INC.
    Date Cleared
    1999-05-25

    (28 days)

    Product Code
    CEP
    Regulation Number
    862.1485
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ovulation Predictor test is used for the qualitative measurement of LH and the detection of LH surge in a woman's urine as an aid in conception by accurately and reliably predicting ovulation. The Ovulation Predictor test is intended for use outside the body (in vitro diagnostic use) by women at home. The Ovulation Predictor test is an over the counter (OTC) device that will be sold under the name Inverness Medical Early Ovulation Predictor, and under various private labels as Early Ovulation Predictor or Ovulation Predictor.
    Device Description
    The Ovulation Predictor test is used for the qualitative measurement of LH and the detection of LH surge in a woman's urine as an aid in conception by accurately and reliably predicting ovulation. The Ovulation Predictor test is intended for use outside the body (in vitro diagnostic use) by women at home. The Ovulation Predictor test is an over the counter (OTC) device that will be sold under the name Inverness Medical Early Ovulation Predictor, and under various private labels as Early Ovulation Predictor or Ovulation Predictor.
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    K Number
    K962866
    Device Name
    OPUS HLH
    Manufacturer
    BEHRING DIAGNOSTICS, INC.
    Date Cleared
    1996-08-23

    (31 days)

    Product Code
    CEP
    Regulation Number
    862.1485
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OPUS hLH is a fluorogenic enzyme assay for use with the OPUS analyzers used in the quantitative measurement of lutenizing hormone (LH) in serum or plasma.
    Device Description
    OPUS hLH is based on the principle of sandwich binding immunoassay. Each test module contains a solid phase anti-LH polyclonal antibody immobilized onto glass fiber. An anti-LH monoclonal antibody/alkaline phosphatase conjugate solution and a wash/substrate soluiton (4-methylumbellifery|phosphate) are sealed in separate wells within the test module.
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    K Number
    K962041
    Device Name
    ACS LH2 IMMUNOASSAY
    Manufacturer
    CIBA CORNING DIAGNOSTICS CORP.
    Date Cleared
    1996-06-21

    (24 days)

    Product Code
    CEP
    Regulation Number
    862.1485
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of ACS LH2 is for the quantitative determination of LH in serum using the Ciba Corning Automated Chemiluminescence Systems.
    Device Description
    The Ciba Corning ASC LH2 assay is a two-site chemilumometric (sandwhich) assay which uses constant amounts of two antibodies that have specificity for the intact LH molecule. The first antibody or Lite Reagent is a monoclonal mouse anti-LH antibody labeled with acridinium ester. The second antibody or solid phase is a monoclonal mouse anti-LH antibody covalently coupled to paramagnetic particles. A direct relationship exists between the LH in a sample and the relative light units (RLUs) detected by the ACS:180 systems.
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