Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K012805
    Device Name
    AUTOMARQER
    Manufacturer
    HAMILTON THORNE RESEARCH
    Date Cleared
    2002-03-13

    (204 days)

    Product Code
    POV, GKZ
    Regulation Number
    864.5220
    Why did this record match?
    Applicant Name (Manufacturer) :

    HAMILTON THORNE RESEARCH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AutoMARQER™ is a differential spectrophotometer/reflectometer for sperm analysis and quantification, using MARQ™ Plus Test Kits.
    Device Description
    The AutoMARQER™ functions as a differential spectrophotometer / reflectometer, using MARQ™ Plus Test Kits* for sperm analysis. The AutoMARQER conducts sequential measurement operations on a specimen introduced into the instrument on a special MARQ™ Plus Test Kit cassette designed for use with the AutoMARQER. When using the FertilMARQ Plus Test Kit,* the AutoMARQER measures sperm concentration, motility and velocity. The AutoMARQER performs as a spectrophotometer when measuring specimen concentration. When measuring motility and velocity, it measures light scatter that occurs as sperm intercept its laser beam. It measures number of sperm in a beam directly by counting sperm cells crossing the beam and determines their velocity by the length of bearn passage. Since the beam diameter is known, the crossing time gives the sperm velocity
    Ask a Question
    K Number
    K000380
    Device Name
    FOTOMASTER
    Manufacturer
    HAMILTON THORNE RESEARCH
    Date Cleared
    2000-05-03

    (86 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    HAMILTON THORNE RESEARCH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K990184
    Device Name
    AUTOMARQER
    Manufacturer
    HAMILTON THORNE RESEARCH
    Date Cleared
    1999-03-19

    (58 days)

    Product Code
    POV, GKZ
    Regulation Number
    864.5220
    Why did this record match?
    Applicant Name (Manufacturer) :

    HAMILTON THORNE RESEARCH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Automarqer™ is a differential spectrophotometer for quantification of results using MARQTM Test Kits for sperm analysis.
    Device Description
    The Automarqer™ is a differential spectrophotometer for quantification of results for sperm analysis. The MARQ test kits employ a unique test cassette with four wells, each containing a filter to retain the test reagents and sample suspension. The test cassette is designed to be inserted into the Automarqer for reading of results after the sample has been processed. The Automarger provides the numeric analysis of the quantity of sperm or other sperm ejaculate component being evaluated. The Automarqer operates by measuring the well reflectivity in two wavelengths (red and green) and deriving the optical absorption in DNA-specific dyes within the wells, generated by the staining reagents used in the MARQ test kits. Each well emits a signal in the color with which it is illuminated (either red or blue dye). The first well of the test cassette provides a standard signal (using a standardized latex bead suspension), the second well provides a null signal, and the third and fourth wells provide sample signals. The Automarqer contains an optical assembly, microprocessor and program, cassette position sensor and readout screen. Software in the microprocessor ROM directs the operations. The microprocessor detects position of the cassette as each well is inserted, stores the value of the signal from each well separately under red and green wavelength illuminations, and computes the corresponding reflectivity of the sample, using the scale defined by the difference between the first two wells (the standard signal and the null signal). In this way, the system is self-calibrating on each cassette.
    Ask a Question

    Page 1 of 1