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510(k) Data Aggregation

    K Number
    K120664
    Device Name
    PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM
    Manufacturer
    ABAXIS, INC.
    Date Cleared
    2012-04-24

    (50 days)

    Product Code
    JGY
    Regulation Number
    862.1705
    Why did this record match?
    Product Code :

    JGY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Piccolo Triglycerides - Capillary Test System used with the Piccolo xpress Chemistry Analyzer is intended for the in vitro quantitative determination of triglycerides in capillary (fingerstick) heparinized whole blood in a clinical laboratory setting or point-of-care location. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, and other diseases involving lipid metabolism, or various endocrine disorders.
    Device Description
    The Piccolo® Lipid Panel - Capillary Reagent Disc (which contains the Piccolo® Triglycerides - Capillary Test System) is designed to separate a heparinized whole blood sample into plasma and blood cells. The disc meters the required quantity of plasma and diluent, mixes the plasma with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted plasma mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analyzer.
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    K Number
    K023639
    Device Name
    PICCOLO TRIGLYCERIDES TEST SYSTEM
    Manufacturer
    ABAXIS, INC.
    Date Cleared
    2003-01-24

    (86 days)

    Product Code
    JGY
    Regulation Number
    862.1705
    Why did this record match?
    Product Code :

    JGY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Piccolo Triglycerides Test System used with the Piccolo Point-of-Care Chemistry Analyzer is intended for the in vitro quantitative determination of triglycerides in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, and other diseases involving lipid metabolism, or various endocrine disorders.
    Device Description
    The Piccolo® Lipid Panel Reagent Disc (which contains the Piccolo® Triglycerides Test System) is designed to separate a heparinized whole blood sample into plasma and blood cells. The disc meters the required quantity of plasma and diluent, mixes the plasma with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted plasma mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analvzer. Alternately, the disc mav also be used with serum.
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    K Number
    K000586
    Device Name
    BIOSCANNER TRIGLYCERIDES TEST STRIPS
    Manufacturer
    POLYMER TECHNOLOGY SYSTEMS, INC.
    Date Cleared
    2000-07-03

    (132 days)

    Product Code
    JGY
    Regulation Number
    862.1705
    Why did this record match?
    Product Code :

    JGY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K991894
    Device Name
    BIOSCANNER TRIGLYCERIDES TEST STRIPS
    Manufacturer
    POLYMER TECHNOLOGY SYSTEMS, INC.
    Date Cleared
    2000-05-24

    (356 days)

    Product Code
    JGY, CDT
    Regulation Number
    862.1705
    Why did this record match?
    Product Code :

    JGY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BioScanner Triglycerides test strips are intended to measure triglyceride in whole blood as an aid in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction and other diseases involving lipid metabolism, or various endocrine disorders.
    Device Description
    Triglycerides are hydrolyzed by lipoprotein lipase to glycerol and fatty acid. Glycerol is phosphorylated by glycerol kinase in the presence of adenosine triphosphate (ATP) forming glycerol-3-phosphate and adenosine-5-diphosphate (ADP). The glycerol-3phosphate is oxidized by glycerophosphate oxidase to dihydroxyacetone phosphate and hydrogen peroxide. In the presence of peroxide, peroxidase catalyzes the coupling of 4-AAP (4-aminoantipyrine) with an N,N-disubstituted aniline to form a quinoneimine dye.
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    K Number
    K971005
    Device Name
    TRIGLYCERIDES
    Manufacturer
    DERMA MEDIA LAB., INC.
    Date Cleared
    1997-04-21

    (33 days)

    Product Code
    JGY
    Regulation Number
    862.1705
    Why did this record match?
    Product Code :

    JGY

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

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