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510(k) Data Aggregation

    K Number
    K982056
    Device Name
    RAICHEM CO2 REAGENT
    Date Cleared
    1998-06-24

    (15 days)

    Product Code
    Regulation Number
    862.1160
    Why did this record match?
    Applicant Name (Manufacturer) :

    REAGENTS APPLICATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The use of this reagent is indicated for the measurement of CO2 levels in serum or plasma on manual or automated systems. The measurement of serum or plasma CO2 content is useful in the assessment of disturbance of acid base balance in respiratory or metabolic acidosis and alkalosis
    Device Description
    This reagent is intended for the quantitative in vitro enzymatic determination of CO2 in serum or plasma on manual or automated systems. The method used in the present procedure is based on the following reactions. Carbon dioxide, in the form of bicarbonate ions, reacts with phosphoenolpyruvate (PEP) to form oxaloacetate and phosphate. This reaction is catalyzed by the enzyme phosphoenolpyruvate carboxylase (PEPC). PEP + HCO3- - PERC > oxaloacetate + H2PO4 This reaction is coupled with a second enzymatic reaction. Oxaloacetate, in the presence of malate dehydrogenase (MDH), is converted to malate, by reduced nicotinamide adenine dinucleotide (NADH). In this reaction one molecule of NADH is oxidized for each molecule of oxaloacetate present. oxaloacetate + NADH + H - MDH > malate + NAD The decrease in absorbance resulting from the oxidation of NADH is proportional to the original concentration of CO2 in the sample. Raichem wishes to market an extended stability formulation modification of the predicate device. Slight variations in the concentrations of ingredients were made to achieve an extended reconstituted stability of one year at 2 to 8 °C. The assay procedure and timing of the assay is the same as that of the predicate device.
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    K Number
    K972853
    Device Name
    CHOLESTEROL RAPID LIQUID REAGENT
    Date Cleared
    1997-09-24

    (89 days)

    Product Code
    Regulation Number
    862.1175
    Why did this record match?
    Applicant Name (Manufacturer) :

    REAGENTS APPLICATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This reagent is intended for the rapid quantitative in-vitro measurement of total serum or plasma cholesterol concentration, utilizing manual or automated analyzers. The determination of serum plasma is one of the important tools in the diagnosis and classification of lipemia. Other conditions, such as hepatic and thyroid diseases, influence cholesterol levels.
    Device Description
    Cholestero! Rapid |Liquid Reagent
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