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510(k) Data Aggregation

    K Number
    K103373
    Device Name
    SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722
    Manufacturer
    BECKMAN COULTER, INC.
    Date Cleared
    2011-02-07

    (82 days)

    Product Code
    DIH
    Regulation Number
    862.3240
    Why did this record match?
    Product Code :

    DIH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    System reagent for the quantitative determination of Cholinesterase activity (E.C. 3.1.1.8) in human serum and plasma on Beckman Coulter Synchron CX® Pro System(s), Synchron LX® Pro System(s) and UniCel® DxC 600/800 System(s). Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning).
    Device Description
    System reagent for the quantitative determination of Cholinesterase activity (E.C. 3.1.1.8) in human serum and plasma on Beckman Coulter Synchron CX® Pro System(s), Synchron LX® Pro System(s) and UniCel® DxC 600/800 System(s). A cholinesterase test system is a device intended to measure cholinesterase (an enzyme that catalyzes the hydrolysis of acetylcholine to choline) in human specimens. There are two principal types of cholinesterase in human tissues. True cholinesterase is present at nerve endings and in erythrocytes (red blood cells) but is not present in plasma. Pseudo cholinesterase is present in plasma and liver but is not present in erythrocytes. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning). The method is based on the recommendations of the German Society for Clinical Chemisty (Deutsche Gesellschaft für Klinische Chemie, DGKCh). Cholinesterase catalyses the hydrolysis of butyrytthiocholine to butyrate and thiocholine. Thiocholine reduces yellow hexacyanoferrate (III) to colorless hexacvanoferrate (II). The decrease in absorbance at 410 nm is directly proportional to the cholinesterase activity in the sample.
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    K Number
    K061093
    Device Name
    CHOLINESTERASE GEN.2 TEST SYSTEM
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Date Cleared
    2006-07-03

    (75 days)

    Product Code
    DIH
    Regulation Number
    862.3240
    Why did this record match?
    Product Code :

    DIH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cholinesterase Gen.2 Test System is an in vitro test for the quantitative determination of the catalytic activity of cholinesterase (EC 3.1.1.8; acylcholine acylhydrolase) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders.
    Device Description
    The Cholinesterase Gen.2 Test System is an in vitro test for the quantitative determination of the catalytic activity of cholinesterase in serum and plasma. The test is based on the butyrylthiocholine method. Cholinesterase catalyzes the hydrolysis of butyrylthiocholine to thiocoline and butyrate. Thiocholine reduces the yellow substrate hexacyanoferrate III to the almost colorless hexacyanoferrate II. The decrease in color is measured spectrophotometrically. The calibrator is the Calibrator for automated systems (C.f.a.s; and the recommended control materials are Precinorm U or Precinorm U Plus; and Precipath U or Precipath U plus.
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    K Number
    K051444
    Device Name
    SENTINEL CHOLINESTERASE LIQUID
    Manufacturer
    SENTINEL CH. SRL
    Date Cleared
    2005-06-20

    (18 days)

    Product Code
    DIH
    Regulation Number
    862.3240
    Why did this record match?
    Product Code :

    DIH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sentinel Cholinesterase Liquid assay is used to measure cholinesterase in human specimens. There are two principal type of cholinesterase in human tissues. True cholinesterase is present at nerve endings and in erythrocytes but is not present in plasma. Pseudo cholinesterase is present in plasma and liver but is note present in erythrocytes. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition and disorders. For In Vitro diagnostics use only. CFR 862.3240
    Device Description
    Sentinel Cholinesterase Liquid is an in vitro diagnostic assay for the quantitative determination of cholinesterase in serum and plasma.
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    K Number
    K030045
    Device Name
    OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114)
    Manufacturer
    OLYMPUS AMERICA, INC.
    Date Cleared
    2003-02-21

    (46 days)

    Product Code
    DIH
    Regulation Number
    862.3240
    Why did this record match?
    Product Code :

    DIH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Reagent for the determination of cholinesterase concentrations in human serum and plasma using the Olympus family of clinical chemistry analyzers. Measurement of serum cholinesterase has been used to assess liver function and to investigate the variants of cholinesterase enzyme. It is also useful in predicting susceptibility to prolonged apnea after the administration of succinylcholine and in monitoring excessive exposure to organophosphorus insecticides.
    Device Description
    Not Found
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    K Number
    K023992
    Device Name
    WIENER LAB COLINESTERASA AA
    Manufacturer
    WIENER LABORATORIES S.A.I.C.
    Date Cleared
    2003-02-12

    (72 days)

    Product Code
    DIH
    Regulation Number
    862.3240
    Why did this record match?
    Product Code :

    DIH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The WIENER LAB. Colinesterasa AA test system is a quantitative in vitro diagnostic device intended to be used in the quantitative determination of cholinesterase (an enzyme that catalyzes the hydrolysis of acetylcholine to choline) in human specimens, on both manual and automated systems. There are two principal types of cholinesterase in human tissues. True cholinesterase is present at nerve endings and in erythrocytes (red blood cells) but is not present in plasma. Pseudo cholinesterase is present in plasma and liver but is not present in erythrocytes. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning).
    Device Description
    Kinetic Method. The principle is based on the following reaction system: Cholinesterase Butyrylthiocholine + H2O -> Thiocholine + Butyrate Thiocholine + DTNB -> 2-Nitro-5-Mercapto-benzoate The cholinesterase activity is determined by measuring the rate of absorbance change at 405 nm. DTNB: 5,5'-Dithiobis-2-Nitrobenzoic Acid. ChE: serum or plasma cholinesterase.
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    K Number
    K013750
    Device Name
    ADVIA 1650 CHOLINESTERASE ASSAY
    Manufacturer
    BAYER DIAGNOSTICS CORP.
    Date Cleared
    2002-01-18

    (66 days)

    Product Code
    DIH
    Regulation Number
    862.3240
    Why did this record match?
    Product Code :

    DIH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ADVIA 1650 Cholinesterase in vitro diagnostic procedure is intended to measure cholinesterase in human I he ADVANT 1050 Onlinesser any and 650 system. Such measurement is used in the diagnosis and treatment Scruit and pashia on the Dayer AD Previous liver diseases such as cirrhosis and acute and chronic hepatitis.
    Device Description
    The Cholinesterase in vitro diagnostic procedure is intended to measure cholinesterase enzyme activity in human serum, plasma (lithium heparin) on the Bayer ADVIA® 1650 Such measurement is used in the diagnosis and treatment of organophosphorus System. poisoning and certain liver diseases such as cirrhosis, acute and chronic hepatitis.
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    K Number
    K002792
    Device Name
    CARESIDE CHOLINESTERASE
    Manufacturer
    CARESIDE, INC.
    Date Cleared
    2000-11-08

    (62 days)

    Product Code
    DIH
    Regulation Number
    862.3240
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    Product Code :

    DIH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001344
    Device Name
    ADVIA IMS
    Manufacturer
    BAYER CORP.
    Date Cleared
    2000-06-26

    (60 days)

    Product Code
    DIH
    Regulation Number
    862.3240
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    Product Code :

    DIH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K961656
    Device Name
    TEST-MATE CHE CHOLINESTERASE TEST SYSTEM
    Manufacturer
    EQM RESEARCH, INC.
    Date Cleared
    1996-11-26

    (210 days)

    Product Code
    DIH
    Regulation Number
    862.3240
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    Product Code :

    DIH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K943367
    Device Name
    IL TEST CHOLINESTERASE
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Date Cleared
    1996-02-05

    (572 days)

    Product Code
    DIH
    Regulation Number
    862.3240
    Why did this record match?
    Product Code :

    DIH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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