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510(k) Data Aggregation
K Number
K012805Device Name
AUTOMARQER
Manufacturer
HAMILTON THORNE RESEARCH
Date Cleared
2002-03-13
(204 days)
Product Code
POV, GKZ
Regulation Number
864.5220Why 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
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K Number
K000380Device Name
FOTOMASTER
Manufacturer
HAMILTON THORNE RESEARCH
Date Cleared
2000-05-03
(86 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
HAMILTON THORNE RESEARCH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K990184Device Name
AUTOMARQER
Manufacturer
HAMILTON THORNE RESEARCH
Date Cleared
1999-03-19
(58 days)
Product Code
POV, GKZ
Regulation Number
864.5220Why 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.
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