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    K Number
    K051733
    Device Name
    ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL
    Manufacturer
    DRG INTL., INC.
    Date Cleared
    2005-12-07

    (162 days)

    Product Code
    NHG
    Regulation Number
    862.1205
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL

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

    An enzyme immunoassay for the quantitative in vitro diagnostic measurement of active free cortisol (hydrocortisone and hydroxycorticosterone) in saliva. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.

    Device Description

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

    AI/ML Overview

    Here's an analysis of the provided text regarding the DRG Salivary Cortisol ELISA, focusing on acceptance criteria and study details:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are implied through the performance data presented, as explicit criteria (e.g., "must achieve X correlation") are not stated. The performance is reported against other commercially available methods or standard analytical techniques.

    Performance MetricImplied Acceptance Criteria (Based on context)Reported Device Performance
    Method Comparison (vs. LIA)High correlation (e.g., >0.85)0.872 (Study 1, n=114)
    High correlation (e.g., >0.95) for expanded study0.9795 (Expanded Study 1, n=40)
    Method Comparison (vs. EIA)High correlation (e.g., >0.90)0.936 (Study 2, n=72)
    High correlation (e.g., >0.95) for expanded study0.9920 (Expanded Study 2, n=40)
    Method Comparison (vs. LC-MS)High correlation (e.g., >0.85)0.89056 (Study 3, n=28)
    Sensitivity (Lowest Detectable Limit)As low as reasonably achievable for clinical utility (no specific numerical criterion given)0.537 ng/mL or 0.0537 ug/dl at 95% confidence limit
    Specificity (Cross-Reactivity)Low cross-reactivity with structurally similar compoundsCortisol: 100%, Corticosterone: 29.00%, Cortisone: 3.00%, most others
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