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510(k) Data Aggregation
K Number
K103373Device Name
SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722
Manufacturer
BECKMAN COULTER, INC.
Date Cleared
2011-02-07
(82 days)
Product Code
DIH
Regulation Number
862.3240Why 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
K061093Device Name
CHOLINESTERASE GEN.2 TEST SYSTEM
Manufacturer
ROCHE DIAGNOSTICS CORP.
Date Cleared
2006-07-03
(75 days)
Product Code
DIH
Regulation Number
862.3240Why 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
K051444Device Name
SENTINEL CHOLINESTERASE LIQUID
Manufacturer
SENTINEL CH. SRL
Date Cleared
2005-06-20
(18 days)
Product Code
DIH
Regulation Number
862.3240Why 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
K030045Device Name
OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114)
Manufacturer
OLYMPUS AMERICA, INC.
Date Cleared
2003-02-21
(46 days)
Product Code
DIH
Regulation Number
862.3240Why 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
K023992Device Name
WIENER LAB COLINESTERASA AA
Manufacturer
WIENER LABORATORIES S.A.I.C.
Date Cleared
2003-02-12
(72 days)
Product Code
DIH
Regulation Number
862.3240Why 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
K013750Device Name
ADVIA 1650 CHOLINESTERASE ASSAY
Manufacturer
BAYER DIAGNOSTICS CORP.
Date Cleared
2002-01-18
(66 days)
Product Code
DIH
Regulation Number
862.3240Why 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
K002792Device Name
CARESIDE CHOLINESTERASE
Manufacturer
CARESIDE, INC.
Date Cleared
2000-11-08
(62 days)
Product Code
DIH
Regulation Number
862.3240Why did this record match?
Product Code :
DIH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001344Device Name
ADVIA IMS
Manufacturer
BAYER CORP.
Date Cleared
2000-06-26
(60 days)
Product Code
DIH
Regulation Number
862.3240Why did this record match?
Product Code :
DIH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K961656Device Name
TEST-MATE CHE CHOLINESTERASE TEST SYSTEM
Manufacturer
EQM RESEARCH, INC.
Date Cleared
1996-11-26
(210 days)
Product Code
DIH
Regulation Number
862.3240Why did this record match?
Product Code :
DIH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K943367Device Name
IL TEST CHOLINESTERASE
Manufacturer
INSTRUMENTATION LABORATORY CO.
Date Cleared
1996-02-05
(572 days)
Product Code
DIH
Regulation Number
862.3240Why did this record match?
Product Code :
DIH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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