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510(k) Data Aggregation

    K Number
    K022108
    Device Name
    THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050
    Manufacturer
    THERMO DMA, INC.
    Date Cleared
    2002-07-25

    (27 days)

    Product Code
    JIX, CAL
    Regulation Number
    862.1150
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERMO DMA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Thermo DMA Data-Cal Calibrator is intended for use in the calibration of clinical chemistry assays.
    Device Description
    Thermo DMA's Data-Cal is intended for use as a reference material in the single point calibration of clinical chemistry procedures.
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    K Number
    K012878
    Device Name
    THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609
    Manufacturer
    THERMO DMA, INC.
    Date Cleared
    2001-10-16

    (49 days)

    Product Code
    JIS, CAL
    Regulation Number
    862.1150
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERMO DMA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This reagent is intended for use with Thermo Trace Ammonia Reagent(510(k) number K(74620) to establish points of reference that are used in the determination of Ammonia in human plasma.
    Device Description
    The Thermo Trace Ammonia Standards are aqueous (ammonia free deionized water) solutions of Ammonium Sulfate (Merck GR ACS (ammonia rece delonioa navis) preservative (Sodium Azide). The Thermo Trace Ammonia Standard set is intended for in vitro diagnostic use with Thermo Trace Ammonia Reagent (K974620) to establish points of reference that are used in the determination of Ammonia in human plasma.
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    K Number
    K012518
    Device Name
    TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113
    Manufacturer
    THERMO DMA, INC.
    Date Cleared
    2001-10-09

    (64 days)

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

    THERMO DMA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This reagent is intended for the in vitro quantitative determination of Alkaline Phosphatase in human serum and plasma. Measurements of Alkaline Phosphatase or its isoenzymes are used as in the diagnosis and treatment of liver, bone, parathyroid and intestinal diseases.
    Device Description
    TRACE Scientifics' alkaline phosphatase reagents are intended for the in vitro quantitative determination of alkaline phosphatase in human serum and plasma. The TRACE ALP - AMP (IFCC) method is based on the recommendations of the International Federation of Clinical Chemistry (IFCC). This method utilizes 4-nitrophenylphosphate (4-NPP) as the substrate. Under the optimized conditions ALP present in the sample catalyses the following transphosphorylation reaction. At the pH of the reaction 4-NPP has an intense yellow color. The reagent also contains a metal ion buffer system to ensure that optimal concentrations of metal ions are maintained. The metal ion buffer can also chelate other potentially inhibitory ions, which may be present. The reaction is monitored by measuring the increase in absorbance at 405 nm, which is proportional to the activity of ALP in the serum.
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    K Number
    K012525
    Device Name
    THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235
    Manufacturer
    THERMO DMA, INC.
    Date Cleared
    2001-10-04

    (59 days)

    Product Code
    LCP, ASS
    Regulation Number
    864.7470
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERMO DMA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This reagent is intended for the in vitro quantitative determination of Fructosamine (glycated protein) in human serum when run on the Hitachi 704 automated chemistry analyzer. Measurements of fructosamine are used as an aid for short-term glycemic control related to diabetes management.
    Device Description
    Thermo DMA's fructosamine reagent is intended for the in vitro quantitative determination of Fructosamine in human serum. Under alkaline conditions, analytes with Amadori rearrangements, such as Fructosamine, have reducing activity that can be differentiated from other reducing substances. In the presence of carbonate buffer, fructosamine rearranges to the eneaminol form, which reduces Nitroblue tetrazolium (NBT) to a formazan. The absorbance at 530 nm is measured at two time points and the absorbance change is proportional to the fructosamine concentration. A 10-minute incubation is employed to allow fast reacting interfering reducing substances to react. Removal of endogenous glucose is not required due to the fact that a pH of greater than 11 is required for glucose to reduce NBT.
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