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510(k) Data Aggregation
K Number
K162526Device Name
Creatine Kinase-MB
Manufacturer
ROCHE DIAGNOSTICS
Date Cleared
2017-05-26
(259 days)
Product Code
JHW
Regulation Number
862.1215Why did this record match?
Product Code :
JHW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Creatine Kinase-MB assay is an in-vitro test for the quantitative determination of the catalytic activity of creatine kinase MB subunit (CK-MB) in human serum and plasma on Roche/Hitachi cobas c systems.
Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
Device Description
The Creatine Kinase-MB assay is a two reagent assay for the quantitative determination of creatine kinase-MB (CK-MB) in human serum and plasma on automated clinical chemistry analyzers. The rate of the NADPH formation is directly proportional to the catalytic CK-MB activity. It is determined by measuring the increase in absorbance photometrically.
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K Number
K141265Device Name
ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT
Manufacturer
ELITECHGROUP
Date Cleared
2014-07-18
(64 days)
Product Code
JHW
Regulation Number
862.1215Why did this record match?
Product Code :
JHW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ENVOY®500 CK REAGENT KIT is intended for the quantitative in vitro determination of creatine kinase (CK) in buman serum and plasma using the ENVOY 500 Chemistry System.
It is not intended for use in Point of Care settings.
Creatine phosphokinase and its isoenzymes measurements are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
Device Description
ENVOY CK REAGENT KIT is available as kit only. It consists of a bi-reagent R1 and R2 whose composition,
for R1: 125 mmol/L Imidazole buffer, pH 6.10; 25 mmol/L D-Glucose; 25 mmol/L N-Acetyl-L-Cysteine; 12.5 mmol/L Magnesium acetate; 2.4 mmol/L NADP; 2.0 mmol/L EDTA; > 6800 U/L Hexokinase (microorganism); < 0.1% Sodium azide
for R2: 250 mmol/L Creatine phosphate; 15.2 mmol/L ADP; 25 mmol/L AMP; 103 µmol/L Diadenosine pentaphosphate; ≥ 8800 U/L G-6-PDH (microorganism); < 0.1% Sodium azide.
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K Number
K122083Device Name
ELITECH CLINICAL SYSTEMS CK NAC SL
Manufacturer
ELITECHGROUP
Date Cleared
2012-08-22
(37 days)
Product Code
JHW, JIX, JJY
Regulation Number
862.1215Why did this record match?
Product Code :
JHW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ELITech Clinical Systems CK NAC SL is intended for the quantitative in vitro determination of creatine kinase (CK) in human serum and plasma on ELITech Clinical Systems Selectra analyzers. It is not intended for use in Point of Care settings. Creatine phosphokinase and its isoenzymes measurements are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.
ELITech Clinical Systems ELITROL I and ELITROL II are multi-parametric control sera for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.
Device Description
CK NAC SL is available as kit only. It consists of 2 reagents R1 & reagent R2: Reagent R1 contains: Imidazole buffer (pH 6.10), D-Glucose, N-Acetyl-L-Cysteine, Magnesium acetate, NADP, EDTA, Hexokinase (microorganisms), sodium azide. Reagent R2 contains: Creatine phosphate, ADP, AMP, Diadenosine pentaphosphate, Glucose-6-phosphate Dehydrogenase (G-6-PDH) (micro-organisms), sodium azide.
ELITech Clinical Systems ELICAL2 is a lyophilized calibrator based on human serum containing constituents to ensure optimal calibration. ELICAL 2 is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to the antibodies to HCV and HIV according to FDA-approved methods.
ELITROL I and ELITROL II are two level quality control products consisting of a lyophilized human serum containing constituents at desired levels. ELITROL I and ELITROL II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods.
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K Number
K023744Device Name
WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354
Manufacturer
WIENER LABORATORIES S.A.I.C.
Date Cleared
2003-01-03
(57 days)
Product Code
JHW
Regulation Number
862.1215Why did this record match?
Product Code :
JHW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The "Wiener lab. CK-MB DS UV unitest" test system is a quantitative in vitro diagnostic device intended to measure the activity of the MB isoenzyme of creatine phosphokinase in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
Device Description
Not Found
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K Number
K003158Device Name
ROCHE DIAGNOSTICS CK-MB
Manufacturer
ROCHE DIAGNOSTICS CORP.
Date Cleared
2000-12-18
(69 days)
Product Code
JHW
Regulation Number
862.1215Why did this record match?
Product Code :
JHW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K961501Device Name
ELECSYS CK-MB
Manufacturer
BOEHRINGER MANNHEIM CORP.
Date Cleared
1996-06-11
(54 days)
Product Code
JHW
Regulation Number
862.1215Why did this record match?
Product Code :
JHW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Immunoassay for the in vitro quantitative determination of the MB isoenzyme of creatine kinase (CK-MB) in human serum and plasma.
A creatine phosphokinase / creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine kinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy
Device Description
The Elecsys® CK-MB test principle is based on a two-step sandwich with Streptavidin microparticles and electrochemiluminescence detection.
Total duration of the assay: 9 minutes
1st incubation: 15 µl of sample, a biotinylated monoclonal CK-MB-specific antibody and a monoclonal CK-MB-specific antibody labeled with a ruthenium complex react to form a sandwich complex
2nd incubation: after the addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin.
• The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier.
• Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent bar code.
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