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510(k) Data Aggregation

    K Number
    K060773
    Device Name
    ONLINE TDM PROCAINAMIDE
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Date Cleared
    2006-08-23

    (154 days)

    Product Code
    LAR
    Regulation Number
    862.3320
    Why did this record match?
    Product Code :

    LAR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ONLINE TDM Procainamide assay is for the quantitative determination of procainamide in human serum or plasma on Roche automated clinical chemistry analyzers. Measurements are used in the diagnosis and treatment of procainamide overdose and in monitoring levels of procainamide to help ensure proper therapy.
    Device Description
    The ONLINE TDM Procainamide assay is for the quantitative determination of procainamide in human serum or plasma on Roche automated clinical chemistry analyzers. The proposed labeling indicates the Roche Hitachi 911, 912, 917 and Modular P analyzers can be used with the Roche ONLINE TDM Procainamide reagent kits. The assay is based on a homogeneous enzyme immunoassay technique used for the quantitative analysis of procainamide in human serum or plasma. The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the sample can be measured in terms of enzyme activity. Active enzyme converts oxidized nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that is measured spectrophotometrically. Endogenous serum G6PDH does not interfere because the coenzyme functions only with the bacterial (Leuconostoc mesenteroids) enzyme employed in the assay.
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    K Number
    K032573
    Device Name
    DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110
    Manufacturer
    DADE BEHRING, INC.
    Date Cleared
    2003-10-31

    (72 days)

    Product Code
    LAR
    Regulation Number
    862.3320
    Why did this record match?
    Product Code :

    LAR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dade Behring Dimension® Procainamide (PROC) Flex® reagent cartridge method is used for the quantitative determination of procainamide in serum or plasma. Measurements may be used in the diagnosis and treatment of procainamide overdose, and in therapeutic drug monitoring.
    Device Description
    The Dade Behring Dimension® Procainamide (PROC) Flex® reagent cartridge method is an in vitro diagnostic test that consists of prepackaged reagents in a flexible plastic cartridge for use only on the Dimension® clinical chemistry system. The Dimension® PROC Flex® reagent cartridge assay is based on a homogenous particle-enhanced turbidimetric inhibition immunoassay (PETINIA) which uses a latex particle procainamide conjugate and monoclonal procainamide specific antibody. Procainamide present in the sample competes with procainamide on the particles for available antibody, thereby decreasing the rate of aggregation. Hence, the rate of aggregation is inversely proportional to the concentration of procainamide in the sample. The rate of aggregation is measured using bichromatic turbidimetric readings at 340 nm and 700 nm.
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    K Number
    K010812
    Device Name
    EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229
    Manufacturer
    SYVA CO., DADE BEHRING, INC.
    Date Cleared
    2001-04-13

    (25 days)

    Product Code
    LAR
    Regulation Number
    862.3320
    Why did this record match?
    Product Code :

    LAR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K971716
    Device Name
    PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
    Manufacturer
    BAYER CORP.
    Date Cleared
    1997-06-27

    (49 days)

    Product Code
    LAR
    Regulation Number
    862.3320
    Why did this record match?
    Product Code :

    LAR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This in vitro diagnostic procedure is intended to quantitatively measure procainamide, an antiarrhythmic drug, in human serum or plasma (lithium heparin) using EMIT* (Enzyme Multiplied Immunoassay Technique) technology on a Bayer Immuno 17M system. Measurements of procainamide are used in the diagnosis and treatment of procainamide overdose and in monitoring serum or plasma levels of procainamide to ensure appropriate therapy. This diagnostic method is not intended for use on any other system.
    Device Description
    This in vitro method is intended to quantitatively measure procainamide, an antiarrhythmic drug, in human serum or plasma (lithium heparin) using Syva EMIT® Procainamide Assay on a Bayer Immuno-19 system.
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    K Number
    K963306
    Device Name
    CEDIA N-ACETYLPROCAINAMIDE ASSAY
    Manufacturer
    BOEHRINGER MANNHEIM CORP.
    Date Cleared
    1996-10-29

    (68 days)

    Product Code
    LAR
    Regulation Number
    862.3320
    Why did this record match?
    Product Code :

    LAR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Immunoassay for the in vitro quantitative determination of N-acetylprocainamide in human serum and plasma.
    Device Description
    The CEDIA® N-acetylprocainamide Assay is based on the bacterial enzyme ß-galactosidase, which has been genetically engineered into two inactive fragments. These fragments spontaneously reassociate to form fully active enzyme that, in the assay format, cleaves a substrate, generating a color change that can be measured spectrophotometrically. In the assay, N-acetylprocainamide in the sample competes with analyte conjugated to one inactive frayment of B-galactosidase for antibody binding site. If analyte is present in the sample, it binds to antibody, leaving the inactive enzyme fragments free to form active enzyme. If analyte is not present in the sample, antibody binds to analyte conjugated on the inactive fragment, inhibiting the reassociation of inactive ß-galactosidase fragments, and no active enzyme is formed.
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    K Number
    K962099
    Device Name
    CEDIA PROCAINAMIDE ASSAY
    Manufacturer
    BOEHRINGER MANNHEIM CORP.
    Date Cleared
    1996-08-27

    (90 days)

    Product Code
    LAR
    Regulation Number
    862.3320
    Why did this record match?
    Product Code :

    LAR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Immunoassay for the in vitro quantitative determination of procainamide in human serum and plasma.
    Device Description
    The CEDIA® Procainamide Assay is based on the bacterial enzyme ßgalactosidase, which has been genetically engineered into two inactive fragments. These fragments spontaneously reassociate to form fully active enzyme that, in the assay format, cleaves a substrate, generating a color change that can be measured spectrophotometrically. In the assay, procainamide in the sample competes with analyte conjugated to one inactive fragment of ß-galactosidase for antibody binding site. If analyte is present in the sample, it binds to antibody, leaving the inactive enzyme fragments free to form active enzyme. If analyte is not present in the sample, antibody binds to analyte conjugated on the inactive fragment, inhibiting the reassociation of inactive ß-galactosidase fragments, and no active enzyme is formed.
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    K Number
    K962463
    Device Name
    PROCAINAMIDE ENZYME IMMUNOASSAY
    Manufacturer
    DIAGNOSTIC REAGENTS, INC.
    Date Cleared
    1996-08-14

    (50 days)

    Product Code
    LAR
    Regulation Number
    862.3320
    Why did this record match?
    Product Code :

    LAR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K955444
    Device Name
    ABBOTT AXSM PROCAINAMIDE ASSAY
    Manufacturer
    ABBOTT LABORATORIES
    Date Cleared
    1996-04-02

    (126 days)

    Product Code
    LAR
    Regulation Number
    862.3320
    Why did this record match?
    Product Code :

    LAR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    for the quantitative determination of procainamide in human serum or plasma (sodium heparin, tripotassium EDTA, potassium oxalate, and sodium citrate).
    Device Description
    automated fluorescence polarization immunoassays (FPIA).
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