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510(k) Data Aggregation

    K Number
    K102841
    Device Name
    PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY
    Manufacturer
    PANTEX, DIV. BIO-ANALYSIS, INC.
    Date Cleared
    2012-05-08

    (587 days)

    Product Code
    NHG
    Regulation Number
    862.1205
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K011323
    Why did this record match?
    Applicant Name (Manufacturer) :

    PANTEX, DIV. BIO-ANALYSIS, INC.

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

    For the in-vitro diagnostic quantitative determination of free and protein bound salivary cortisol in human saliva as an aid in the assessment of Cushing Syndrome and Addison's Disease. Measurements of cortisol in saliva are used in the diagnosis and treatment of disorders of the adrenal gland.

    Device Description

    The kit consists of a 96 well GARGG (Goat Anti-Rabbit Gamma Globulin) coated microplate (12x8 breakable strip wells), seven ready-to-use calibrators (range 0.1-30 ng/ml) of gravimetrically prepared cortisol from a commercial source (Steraloids) and compared and traced to NIST cortisol, low and high controls, anti-Cortisol (rabbit), 10X concentrated Cortisol (analog)-peroxidase, substrate solution, stop reaction solution and 10X concentrated wash solution.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Pantex AM/PM Salivary Cortisol EIA Kit, based on the provided text:

    The provided text focuses on the analytical performance of the Pantex AM/PM Salivary Cortisol EIA Kit and its equivalence to a predicate device. It demonstrates the device's ability to accurately and reliably measure salivary cortisol levels.

    1. Table of Acceptance Criteria and Reported Device Performance

    Performance CharacteristicAcceptance Criteria (Implied / Contextual)Reported Device Performance
    Precision/Reproducibility%CV ≤ 10% (for intra-assay, inter-assay, inter-lot)Intra-assay: Low (5.4%), Medium (6.7%), High (6.3%) %CV
    Inter-assay: Low (6.3%), Medium (7.2%), High (2.8%) %CV
    Inter-lot: %CV range of 0.9% to 7.4% for various samples and controls.
    LinearityDesired Recovery % (Typically 90-110%)Recovery ranging from 93.0% to 101.4% across 10 concentrations
    RecoveryDesired Recovery % (Typically 90-110%)Recovery ranging from 93.7% to 103.9% across 10 spiked samples
    Reagent StabilityDemonstrated shelf life9 months when stored at 2-8°C
    Sample StabilityDemonstrated stability under various conditionsRoom Temperature (20-30°C): Up to 7 days
    37°C: Up to 7 days
    2-8°C: Up to 7 days
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