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    K Number
    K062204
    Device Name
    ARCHITECT CORTISOL ASSAY
    Manufacturer
    SERADYN INC.
    Date Cleared
    2006-09-22

    (52 days)

    Product Code
    JFT,JIT
    Regulation Number
    862.1205
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K033731
    Why did this record match?
    Device Name :

    ARCHITECT CORTISOL ASSAY

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

    ARCHITECT® Cortisol is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cortisol in human serum, plasma or urine on the ARCHITECT i System. The ARCHITECT Cortisol assay is intended for use as an aid in the diagnosis and treatment of adrenal disorders.

    The ARCHITECT Cortisol Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of cortisol in human serum, plasma or urine.

    Device Description

    The ARCHITECT Cortisol assay is a delayed one-step immunoassay for the quantitative determination of cortisol in human serum, plasma or urine using CMIA technology with flexible assay protocols, referred to as Chemiflex®.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study details for the ARCHITECT Cortisol assay:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Test CategoryAcceptance CriteriaReported Device Performance
    LinearityTarget +/- 20% Deviation (at 0% dilution for both serum pools)- 65 ug/dL Serum Pool: %DLP ranged from -8% to 4% for diluted samples. At the 0% dilution, the difference was-1.6 ug/dL, compared to the target value of N/A, which is acceptable relative to the ±20% deviation criteria. - 8 ug/dL Serum Pool: %DLP ranged from -12% to 3% for diluted samples. At the 0% dilution, the difference was-0.2 ug/dL, which is acceptable relative to the ±20% deviation criteria.
    Accuracy (Recovery)Serum: Target Recovery 100 ± 15% Urine: Target Recovery 100 ± 20%- Serum: % Recovery ranged from 86.1% to 98.5%. All values are within the acceptance criteria of 100 ± 15% (i.e., 85% to 115%). - Urine: % Recovery ranged from 84.6% to 100.9%. All values are within the acceptance criteria of 100 ± 20% (i.e., 80% to 120%).
    Sensitivity (LoD)Assay claim of LoD = 0.8 ug/dL is supported by data.- ARCHITECT i2000 LoD = 0.401 ug/dL - ARCHITECT i2000SR LoD = 0.255 ug/dL - Functional sensitivity (20% CV): Serum = 0.8 ug/dL, Urine = 1 ug/dL. All reported LoD values are less than or equal to the claimed 0.8 ug/dL for serum, and urine is close at 1 ug/dL, thus supporting the claim.
    Method ComparisonThe results of the Method comparison study met the design goals and acceptance criteria. (Specific numerical criteria not provided in the summary)The summary states that "The results of the Method comparison study met the design goals and acceptance criteria." No specific numerical values for agreement or bias are provided.
    PrecisionSerum:
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