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510(k) Data Aggregation

    K Number
    K201442
    Device Name
    Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers
    Manufacturer
    Diatron Group
    Date Cleared
    2020-07-31

    (60 days)

    Product Code
    LAF
    Regulation Number
    862.3610
    Why did this record match?
    Applicant Name (Manufacturer) :

    Diatron Group

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers is intended for the qualitative determination of d-methamphetamine in human urine at a cutoff value of 500 ng/mL. The system was calibrated with d-methamphetamine. The assay provides a rapid screening procedure for determining the presence of d-methamphetamine in urine. The assay provides only a preliminary analytical result. A more specific alternative analytical chemistry method must be used in order to obtain a confirmed analytical result. Gas or Liquid Chromatography/Mass Spectrometry (GC/MS or LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
    Device Description
    Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers is intended for the qualitative determination of methamphetamine in human urine, at a cutoff value of 500 ng/mL. The assay is designed for laboratory use by trained professionals with various automated clinical chemistry analyzers. This assay provides a rapid screening procedure for assessing the presence of d-methamphetamine in urine. The assay provides only a preliminary analytical result reported as a positive or negative. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. Gas or liquid chromatography/mass spectrometry (GC/MS or LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive. The analyzer photometer reads the absorbance at 340mm at time intervals dictated by the Methamphetamine application stored in the analyzer memory, and the change in absorbance is calculated automatically.
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    K Number
    K101741
    Device Name
    DIATRON PICTUS 400
    Manufacturer
    DIATRON GROUP
    Date Cleared
    2011-01-25

    (217 days)

    Product Code
    CGA, CEM, CGZ, JGS, JJE
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIATRON GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Autoanalyzer Pictus 400 is designed for Clinical Laboratory Use, with direct determination of Na, K, Cl in serum, and Glucose in serum, and to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used. Sodium measurements are used for monitoring electrolyte imbalances. Potassium measurements are used for diagnosis in diseases with high and low Potassium levels. Chloride measurements are primarily use to detect and treatment of metabolic disorders. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
    Device Description
    Not Found
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