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510(k) Data Aggregation

    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
    Predicate For
    K242505
    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: < 20% total CV Urine: < 20% total CV- Serum: Total CVs ranged from 2.5% to 6.2%. All reported total CVs are well below the <20% acceptance criterion. - Urine: Total CVs ranged from 3.8% to 6.4%. All reported total CVs are well below the <20% acceptance criterion.
    Interferences (Endogenous Substances)Not explicitly stated but inferred to be within acceptable clinical limits (e.g., typically ±10% or similar).- Serum: % Interference ranged from -7.8% to +13.2%. - Urine: % Interference ranged from -4.6% to 6.1%.
    Interferences (HAMA & RF)Acceptance Criteria: 100 ± 15% Recovery (for spiked samples)- HAMA: Grand Mean % Recovery = 100.1%, which is within 100 ± 15%. Individual % Recovery values ranged from 97.8% to 102.8%. - Rheumatoid Factor: Grand Mean % Recovery = 94.1%, which is within 100 ± 15%. Individual % Recovery values ranged from 89.7% to 102.1%.
    AnticoagulantsNo significant difference between serum and plasma recovery.The summary states: "The results indicate that there is no significant difference between the recovery of Cortisol in serum or plasma. The collection tubes evaluated show no adverse effects on the recovery of Cortisol, within the experimental error for the spiking study." This confirms the acceptance criterion.
    Specificity (Cross-Reactivity)Not explicitly stated but inferred to be low values to demonstrate specificity.Most cross-reactants showed very low % Cross Reactivity (0.0% to 2.8%). Noted exceptions were Fludrocortisone (36.8%) and Prednisolone (12.5%). The document doesn't explicitly state an acceptance criterion for cross-reactivity, but these values are reported.
    Calibration Curve Stability30 days stability.A 30-day calibration curve stability is supported by the data.
    Reagent On-Board Stability30 days stability.A 30-day on-board reagent stability claim is supported by the data.

    2. Sample Size Used for the Test Set and Data Provenance:

    • Linearity: The study used a "regression analysis plot" and involved constructing "r regression and regression standard error (Reg SE)" for "each pool." The number of unique samples or data points for each dilution is not explicitly stated in the table, but it shows results for dilution range from 0% to 100% for two serum pools (65 ug/dL and 8 ug/dL). The guidance used was NCCLS guideline EP6-A. Provenance is not specified (e.g., country, retrospective/prospective).
    • Accuracy: Cortisol was spiked into human serum from 3 donors and human urine from 3 donors. The samples were analyzed in triplicate. Provenance is not specified.
    • Sensitivity:
      • LoB and LoD: 60 blank samples and 120 low-level samples were used to determine LoB and LoD.
      • Functional Sensitivity: Not explicitly stated, but based on CLSI guideline NCCLS EP17-A.
        Provenace of samples not specified.
    • Method Comparison: Patients samples were used (serum and urine). The number of samples is not provided. The study was conducted according to CLSI Guideline NCCLS EP9. Provenance not specified.
    • Precision:
      • 80 replicates (n=80) for each of the three MCC (Multi-constituent Control) levels and three serum panel levels on both the i2000 and i2000SR instruments.
      • 80 replicates (n=80) for each of the four urine panel levels on both the i2000 and i2000SR instruments.
        The study was performed using NCCLS guideline EP5-A2. Provenance not specified.
    • Interferences (Endogenous Substances):
      • Serum: 3 replicates (N=3) for each interferent concentration and Cortisol target concentration.
      • Urine: Data represents a comparison of "Unaltered Urine Control" vs. "Mock spike Control" and then individual interferents. Number of replicates not explicitly stated, but implies multiple measurements.
        The study was conducted using CLSI Guideline NCCLS EP7-A2. Provenance not specified.
    • Interferences (HAMA & RF):
      • HAMA: 10 samples (HAMA-1, HAMA-2 and 8 other samples) were tested.
      • Rheumatoid Factor (RF): 10 positive RF patient samples were assayed.
        Provenance not specified.
    • Specificity: Cortisol was spiked into cortisol-free human serum. Cross-reactant stock concentrates were prepared and spiked into aliquots of the 12 ug/dL cortisol serum. The total number of unique samples/aliquots is not precisely stated but involves a comprehensive list of 37 cross-reactants. Provenance not specified.
    • On-Board Stability: Details on the sample size used for stability studies (number of samples, replicates, etc.) are not provided in the summary. Provenance not specified.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

    The device is an in vitro diagnostic (IVD) assay for quantitative determination of cortisol. The "ground truth" for such devices is typically established through a reference method or known concentrations of analytes, not through human expert interpretation of images or clinical cases. Therefore, the concept of "experts" as in "radiologists with 10 years of experience" is not applicable here.

    • For studies like linearity, accuracy (recovery), sensitivity, and precision, the ground truth is based on:
      • Known concentrations: For spiked samples and controls.
      • Reference method values: For method comparison (in this case, the predicate device Abbott AxSYM Cortisol assay).
    • No information is provided about clinical expert adjudication or establishment of ground truth in the context of clinical expert review.

    4. Adjudication Method for the Test Set:

    Not applicable. As this is an IVD assay measuring an analyte concentration, the results are quantitative and compared against expected values, known concentrations, or results from a predicate device. There is no mention of a human expert adjudication process (e.g., 2+1, 3+1) because that process is typically associated with subjective interpretation tasks (like image review) where there can be disagreement among experts.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

    No. An MRMC study is not relevant for this type of IVD device. MRMC studies are typically used to evaluate the impact of AI on human reader performance, for instance, in diagnostic imaging where human readers interpret cases. This submission is for a standalone laboratory assay that quantifies a biomarker.

    6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

    Yes, the studies presented (linearity, accuracy, sensitivity, precision, interferences, specificity, stability) all represent the standalone performance of the ARCHITECT Cortisol assay without human-in-the-loop assistance in the interpretation of the assay result itself. The assay directly outputs a quantitative value. The human involvement is in performing the test and reviewing the quantitative result, but not in interpreting subjective data for diagnostical decision-making.

    7. The Type of Ground Truth Used:

    The ground truth used for these studies includes:

    • Known (prepared) concentrations: For linearity panels, spiked accuracy samples (serum and urine), and sensitivity studies (blank and low-level samples).
    • Reference method/predicate device comparison: For method comparison, the Abbott AxSYM Cortisol assay served as the comparative "truth" or reference method to demonstrate substantial equivalence.
    • Defined control material values: For precision studies (MCC samples).

    8. The Sample Size for the Training Set:

    This information is not applicable to this type of traditional in vitro diagnostic assay. These assays are developed through chemical and biological formulation and optimization, not through machine learning models that require distinct training sets. The development process involves extensive experimentation and validation, but not in the "training set" sense of AI/ML.

    9. How the Ground Truth for the Training Set Was Established:

    This information is not applicable for the same reason as above. There is no "training set" in the context of machine learning for this device. The development and optimization of the assay's reagents and protocols are based on established analytical chemistry principles and performance characteristics, validated against known standards and reference materials.

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