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510(k) Data Aggregation

    K Number
    K162526
    Device Name
    Creatine Kinase-MB
    Manufacturer
    ROCHE DIAGNOSTICS
    Date Cleared
    2017-05-26

    (259 days)

    Product Code
    JHW
    Regulation Number
    862.1215
    Why 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
    K141265
    Device Name
    ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT
    Manufacturer
    ELITECHGROUP
    Date Cleared
    2014-07-18

    (64 days)

    Product Code
    JHW
    Regulation Number
    862.1215
    Why 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
    K122083
    Device Name
    ELITECH CLINICAL SYSTEMS CK NAC SL
    Manufacturer
    ELITECHGROUP
    Date Cleared
    2012-08-22

    (37 days)

    Product Code
    JHW, JIX, JJY
    Regulation Number
    862.1215
    Why 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
    K023744
    Device 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
    862.1215
    Why 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
    K003158
    Device Name
    ROCHE DIAGNOSTICS CK-MB
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Date Cleared
    2000-12-18

    (69 days)

    Product Code
    JHW
    Regulation Number
    862.1215
    Why 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
    K961501
    Device Name
    ELECSYS CK-MB
    Manufacturer
    BOEHRINGER MANNHEIM CORP.
    Date Cleared
    1996-06-11

    (54 days)

    Product Code
    JHW
    Regulation Number
    862.1215
    Why 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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