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510(k) Data Aggregation

    K Number
    K191350
    Device Name
    ACTIVE® Free Testosterone RIA
    Manufacturer
    Immunotech s.r.o.
    Date Cleared
    2019-12-20

    (214 days)

    Product Code
    CDZ
    Regulation Number
    862.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    Immunotech s.r.o.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Radioimmunoassay for the quantitative measurement of free testosterone in human serum. This assay is intended for in vitro diagnostic use. Free testosterone test is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in female's hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.
    Device Description
    The radioimmunoassay of free testosterone is a competitive assay. The procedure follows the basic principle of radioimmunoassay where there is competition between a radioactive and a non-radioactive antigen for a mixed number of antibody binding sites. The amount of [125]]-labeled testosterone analog bound to the antibody is inversely proportional to the concentration of unlabeled free testosterone present. The separation of the free and bound antigen is achieved by decanting or aspirating the antibody-coated tubes. A standard curve is constructed and unknown free testosterone values are obtained from the curve by interpolation. Kit Content: Free Testosterone Antibody-Coated Tubes: 2 x 50 tubes (ready-to-use) 125|-labeled Testosterone Analog Tracer (YELLOW): one 22 mL vial (ready-to-use) Calibrators: one 1.0 mL vial labeled 0, and seven 0.5 mL vials labeled 1-7 (ready-to-use) Controls: two 0.5 mL vials labeled 1, 2 (ready-to-use)
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