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    K Number
    K052649
    Device Name
    DRG SLV TESTOSTERONE ELISA TEST
    Manufacturer
    DRG INTL., INC.
    Date Cleared
    2006-01-27

    (123 days)

    Product Code
    CDZ
    Regulation Number
    862.1680
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DRG SLV TESTOSTERONE ELISA TEST

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    An Enzyme Immunoassay for the in vitro diagnostic quantitative measurement of free active testosterone in saliva. Measurement of testosterone is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delaved or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.

    Device Description

    The DRG Salivary Testosterone ELISA Kit is based on the competition princible and the microplate separation. An unknown amount of free testosterone present in the sample and a fixed amount of testosterone conjugated with horseradish peroxidase compete for the binding sites of mouse monoclonal testosterone -antiserum coated onto the wells. After one hour incubation the microplate is washed to stop the competition reaction. After addition of the substrate solution the concentration of testosterone is inversely proportional to the optical density measured.

    AI/ML Overview

    The DRG Salivary Testosterone ELISA is a diagnostic device used for the quantitative measurement of free-active testosterone in saliva. The device performance was evaluated through various studies, including method comparison, sensitivity, specificity, reproducibility, recovery, and linearity.

    1. Table of Acceptance Criteria and Reported Device Performance

    Performance MetricAcceptance Criteria (Implicit)Reported Device Performance
    Normal RangeEstablish a 5-95% reference range for apparently healthy adult males and females across different age groups.Determined from 187 adult males (21-75 years) and 188 adult females (21-75 years).
    Males (pg/mL):
    • 21-30: 47.2 - 136.2
    • 31-40: 46.8 - 106.8
    • 41-50: 36.5 - 82.7
    • 51-60: 19.1 - 89.0
    • 61-75: 12.2 - 68.6
      Females (pg/mL):
    • 21-30: 7.9 - 50.4
    • 31-40:
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