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510(k) Data Aggregation

    K Number
    K081709
    Device Name
    OLYMPUS AFP - ALPHA-FETOPROTEIN
    Manufacturer
    OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA)
    Date Cleared
    2009-03-16

    (272 days)

    Product Code
    LOJ, JIT, JJY
    Regulation Number
    866.6010
    Why did this record match?
    Applicant Name (Manufacturer) :

    **OLYMPUS LIFE **SCIENCE RESEARCH EUROPA GMBH (EUROPA)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Olympus AFP assay is a paramagnetic particle (Dynabeads®), chemiluminescent immunoassay for the quantitative determination of alpha-fetoprotein levels in human serum and lithium heparin plasma using the Olympus AU3000i Immunoassay System. The Olympus AFP assay is intended for use as an aid in the management of patients with non-seminomatous germ cell tumors. For in vitro diagnostic use only. The Olympus AFP Calibrator is for calibrating the quantitative Olympus AFP assay on the Olympus AU3000i Immunoassay System. The Olympus AFP Control is used for quality control of the Olympus AFP assay on the Olympus AU3000i Immunoassay System.
    Device Description
    The Olympus Alpha-fetoprotein (AFP) Test System is a paramagnetic particle (Dynabeads®), chemiluminescent immunoassay for the quantitative determination of alpha-fetoprotein levels in human serum and lithium heparin plasma using the Olympus AU3000i Immunoassay System.
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    K Number
    K080435
    Device Name
    OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181
    Manufacturer
    OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA)
    Date Cleared
    2008-09-05

    (199 days)

    Product Code
    CIG
    Regulation Number
    862.1110
    Why did this record match?
    Applicant Name (Manufacturer) :

    **OLYMPUS LIFE **SCIENCE RESEARCH EUROPA GMBH (EUROPA)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    System reagent for the quantitative determination of Direct Bilirubin in human serum on OLYMPUS analyzers. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block. For in vitro diagnostic use.
    Device Description
    The Olympus Direct Bilirubin Reagent (OSR6X181) is a system reagent.
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    K Number
    K080094
    Device Name
    OLYMPUS TOTAL BHCG TEST SYSTEN
    Manufacturer
    OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA)
    Date Cleared
    2008-09-03

    (233 days)

    Product Code
    DHA, JIT, JJX
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    **OLYMPUS LIFE **SCIENCE RESEARCH EUROPA GMBH (EUROPA)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Olympus BhCG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total beta human chorionic gonadotropin (intact BhCG and free ß) levels in human serum using the Olympus AU3000i Immunoassay System. Total BhCG is used for the early detection of pregnancy. For in vitro diagnostic use only. The Olympus ßhCG Calibrator is for calibrating the quantitative Olympus ßhCG assay on the Olympus AU3000i Immunoassay System. The Olympus BhCG Control is used for quality control of the Olympus BhCG assay on the Olympus AU3000i Immunoassay System.
    Device Description
    The Olympus Total BhCG Test System (OS210303). The Olympus BhCG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total beta human chorionic gonadotropin (intact BhCG and free ß) levels in human serum using the Olympus AU3000i Immunoassay System.
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    K Number
    K070708
    Device Name
    OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104
    Manufacturer
    OLYMPUS LIFE & MATERIAL SCIENCE EUROPA GMBH (IRISH
    Date Cleared
    2007-08-21

    (160 days)

    Product Code
    CEC, CDX
    Regulation Number
    862.1695
    Why did this record match?
    Applicant Name (Manufacturer) :

    **OLYMPUS LIFE **& MATERIAL SCIENCE EUROPA GMBH (IRISH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Olympus fT4 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free thyroxine levels in human serum/plasma using the Olympus AU3000i™ Immunoassay System. Measurements obtained by this device are used in the diagnosis and treatment of thyroid disease. For in vitro diagnostic use only. The Olympus T4 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total thyroxine levels in human serum/plasma using the Olympus AU3000i™ Immunoassay System. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases. For in vitro diagnostic use only.
    Device Description
    Not Found
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    K Number
    K070453
    Device Name
    OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL
    Manufacturer
    OLYMPUS LIFE & MATERIAL SCIENCE EUROPA GMBH (IRISH
    Date Cleared
    2007-06-11

    (115 days)

    Product Code
    GHH
    Regulation Number
    864.7320
    Why did this record match?
    Applicant Name (Manufacturer) :

    **OLYMPUS LIFE **& MATERIAL SCIENCE EUROPA GMBH (IRISH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    System reagent for the quantitative determination of D-Dimer in human plasma on OLYMPUS analyzers. Aid in detecting the presence and degree of intravascular coagulation and fibrinolysis, and in monitoring therapy for disseminated intravascular coagulation.
    Device Description
    In this Olympus procedure, the decrease in light intensity transmitted (increase in absorbance) through particles suspended in solution is as a result of complexes formed during the immunological reaction between the D-Dimer of the patient serum and the anti-human D-Dimer antibodies coated on the latex particles
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    K Number
    K070835
    Device Name
    OLYMPUS CK-MB REAGENT
    Manufacturer
    OLYMPUS LIFE & MATERIAL SCIENCE EUROPA GMBH (IRISH
    Date Cleared
    2007-06-04

    (69 days)

    Product Code
    JHY
    Regulation Number
    862.1215
    Why did this record match?
    Applicant Name (Manufacturer) :

    **OLYMPUS LIFE **& MATERIAL SCIENCE EUROPA GMBH (IRISH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    System reagent for the quantitative determination of Creatine Kinase-MB isoenzyme in human serum and plasma on Olympus analyzers. Measurements of Creatine Kinase are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
    Device Description
    In this Olympus procedure: The R1 reagent antibody binds to the M subunit of CK in the serum sample. The B subunit of the enzyme acts on the substrate present in the R2 reagent. CK reversibly catalyzes the transfer of a phosphate group from creatine phosphate to ADP to give creatine and ATP. The ATP is used to produce glucose-6-phosphate and ADP, catalyzed by hexokinase (HK) which requires magnesium ions for maximum activity. The glucose-6-phosphate is oxidized by the action of the enzyme G6P-DH with simultaneous reduction of the coenzyme NADP to give NADPH and 6-phosphogluconate. The rate of increase of absorbance at 340/660 nm due to the formation of NADPH is directly proportional to the activity of CK-MB in the sample.
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