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510(k) Data Aggregation

    K Number
    K240468
    Device Name
    Alkaline Phosphatase
    Manufacturer
    Abbott Laboratories Diagnostics Division
    Date Cleared
    2024-10-16

    (239 days)

    Product Code
    CJE
    Regulation Number
    862.1050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Abbott Laboratories Diagnostics Division

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Alkaline Phosphatase assay is used for the quantitation of alkaline phosphatase in human serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are to be used as an aid in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
    Device Description
    The Alkaline Phosphatase assay is an automated clinical chemistry assay. Alkaline phosphatase in the sample catalyzes the hydrolysis of colorless p-nitrophenyl phosphate (p-NPP) to give p-nitrophenol and inorganic phosphate. At the pH of the assay (alkaline), the p-nitrophenol is in the yellow phenoxide form. The rate of absorbance increase at 404 nm is directly proportional to the alkaline phosphatase activity in the sample. Optimized concentrations of zinc and magnesium ions are present to activate the alkaline phosphatase in the sample.
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    K Number
    K230994
    Device Name
    Alinity i STAT High Sensitivity Troponin-I
    Manufacturer
    Abbott Laboratories Diagnostics Division
    Date Cleared
    2023-05-04

    (27 days)

    Product Code
    MMI
    Regulation Number
    862.1215
    Why did this record match?
    Applicant Name (Manufacturer) :

    Abbott Laboratories Diagnostics Division

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Alinity i STAT High Sensitivity Troponin-I assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of cardiac troponin I (cTnl) in human plasma (lithium heparin) on the Alinity is ystem. The Alinity i STAT High Sensitivity Troponin-I assay is to be used as an aid in the diagnosis of myocardial infarction (MI).
    Device Description
    The Alinity i STAT High Sensitivity Troponin-I Reagent Kit contains: - . Microparticles: 1 bottle (6.6 mL per 100 test cartridge / 33.8 mL per 600 test cartridge). Anti-troponin I (mouse, monoclonal) coated microparticles in TRIS buffer with protein (bovine) stabilizer. Minimum concentration: 0.035% solids. Preservative: ProClin 300. - . Conjugate: 1 bottle (6.1 mL per 100 test cartridge / 33.8 mL per 600 test cartridge). Anti-troponin I (mouse-human chimeric, monoclonal) acridinium-labeled conjugate in MES buffer with protein (bovine) stabilizer and human IgG. Minimum concentration: 0.1 mg/L. Preservative: ProClin 300.
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    K Number
    K202525
    Device Name
    Alinity i STAT High Sensitivity Troponin-I
    Manufacturer
    Abbott Laboratories Diagnostics Division
    Date Cleared
    2022-05-19

    (625 days)

    Product Code
    MMI
    Regulation Number
    862.1215
    Why did this record match?
    Applicant Name (Manufacturer) :

    Abbott Laboratories Diagnostics Division

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Alinity i STAT High Sensitivity Troponin-I assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of cardiac troponin I (cTnI) in human plasma (lithium heparin) on the Alinity i system. The Alinity i STAT High Sensitivity Troponin-I assay is to be used as an aid in the diagnosis of myocardial infarction (MI).
    Device Description
    The Alinity i STAT High Sensitivity Troponin-I Reagent Kit contains: - . Microparticles: 1 bottle (6.6 mL per 100 test cartridge / 33.8 mL per 600 test cartridge). Anti-troponin I (mouse, monoclonal) coated microparticles in TRIS buffer with protein (bovine) stabilizer. Minimum concentration: 0.035% solids. Preservative: ProClin 300. - . Conjugate: 1 bottle (6.1 mL per 100 test cartridge / 33.8 mL per 600 test cartridge). Anti-troponin I (mouse-human chimeric, monoclonal) acridinium-labeled conjugate in MES buffer with protein (bovine) stabilizer and human IgG. Minimum concentration: 0.1 mg/L. Preservative: ProClin 300. The Alinity i STAT High Sensitivity Troponin-I assay is an automated, two-step immunoassay for the quantitative determination of cTnI in human plasma (lithium heparin) using CMIA technology. Sample and anti-troponin I antibody-coated paramagnetic microparticles are combined and incubated. The cTnI present in the sample binds to the anti-troponin I coated microparticles. The mixture is washed. Anti-troponin I acridinium-labeled conjugate is added to create a reaction mixture and incubated. Following a wash cycle, Pre-Trigger and Trigger Solutions are added. The resulting chemiluminescent reaction is measured as a relative light unit (RLU). There is a direct relationship between the amount of cTnI in the sample and the RLU detected by the system optics.
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    K Number
    K191595
    Device Name
    ARCHITECT STAT High Sensitivity Troponin-I
    Manufacturer
    Abbott Laboratories Diagnostics Division
    Date Cleared
    2019-09-13

    (88 days)

    Product Code
    MMI
    Regulation Number
    862.1215
    Why did this record match?
    Applicant Name (Manufacturer) :

    Abbott Laboratories Diagnostics Division

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ARCHITECT STAT High Sensitivity Troponin-I assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of cardiac troponin I (cTnl) in human plasma (dipotassium [K2] EDTA) on the ARCHITECT i2000SR System. The ARCHITECT STAT High Sensitivity Troponin-I assay is to be used as an aid in the diagnosis of myocardial infarction (MI).
    Device Description
    The ARCHITECT STAT High Sensitivity Troponin-I assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cardiac troponin I (cTnI) in human plasma (dipotassium EDTA) using chemiluminescent microparticle immunoassay technology with flexible assay protocols, referred to as Chemiflex. The reagent kit contains anti-troponin I (mouse, monoclonal) coated microparticles and anti-troponin I (mouse-human chimeric, monoclonal) acridinium-labeled conjugate. The procedure involves combining sample and antibody-coated microparticles, incubation and wash, adding acridinium-labeled conjugate, another wash cycle, and then adding Pre-Trigger and Trigger Solutions. The resulting chemiluminescent reaction is measured as relative light units (RLUs), which are directly related to the amount of cTnI in the sample. The cTnI concentration is determined relative to a standard curve.
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