LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K062626
    Device Name
    CORTISOL ELISA
    Manufacturer
    IBL-HAMBURG GMBH
    Date Cleared
    2006-12-20

    (106 days)

    Product Code
    CGR
    Regulation Number
    862.1205
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K010790,K052359
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The IBL Cortisol enzym linked immunosorbent assay is for the in-vitro-diagnostic quantitative determination of cortisol in human serum and saliva.

    The Cortisol ELISA kit is useful as an aid in the differential diagnosis of Cushing syndrome and Addison's disease.

    Device Description

    Solid phase enzyme-linked immunosorbent assay (ELISA) based on the competition principle. An unknown amount of antigen present in the sample and a fixed amount of enzyme labelled antigen compete for the binding sites of the antibodies coated onto the wells. After incubation the wells are washed to stop the competition reaction. After the substrate reaction the intensity of the developed color is inversely proportional to the amount of the antigen in the sample. Results of samples can be determined directly using the standard curve.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and the study proving device performance for the IBL Cortisol ELISA, based on the provided text:

    Acceptance Criteria and Device Performance for IBL Cortisol ELISA

    1. Table of Acceptance Criteria and Reported Device Performance

    The submission document for K062626 does not explicitly state pre-defined acceptance criteria in a dedicated section. However, the performance data presented implicitly serves as the criteria the device met for clearance. Based on the "Device Performance" section, the following can be inferred as the de-facto acceptance measurements:

    Performance MetricAcceptance Criteria (Inferred)Reported Device Performance
    Shelf Life (Complete Kit)At least 9 months at 2-8 °C (based on predicate)9 months at 2-8 °C
    Method Comparison (vs. IBL-Luminescence IA)High correlation (r value close to 1) and acceptable linear regression for both serum and saliva samples.Saliva: IBL-ELISA = 0.92 x IBL-Luminescence IA + 0.06 µg/dL; r = 0.995 (n = 130) Serum: IBL-ELISA = 1.17 x IBL-Luminescence IA - 2.2 µg/dL; r = 0.997 (n = 129)
    Method Comparison (vs. GC/MS)High correlation (r value close to 1) and acceptable linear regression for serum samples.Serum: IBL-ELISA = 0.97 x GCMS + 2.3 µg/dL; r = 0.982 (n = 33)
    InterferenceMinimal effect (+/- 20% of expected) on test results at specified concentrations.Hemoglobin (4.0 mg/mL): 0.06; 0.33; 0.62 µg/dL (Cortisol)Bilirubin (0.5 mg/mL): 0.07; 0.35; 0.63 µg/dL (Cortisol)Triglyceride (30 mg/mL): 0.07; 0.40; 0.75 µg/dL (Cortisol)Thimerosal (0.50 %): 0.19; 0.25; 0.34 µg/dL (Cortisol)Blood (0.125 %): 0.09; 0.26 µg/dL (Cortisol)NaN3 (0.60 %): 0.23; 0.31 µg/dL (Cortisol) (All met the < 20% effect criteria, implied by "do not have a significant effect")
    Analytical Specificity (Cross-Reactivity)Low cross-reactivity for other substances (e.g., < 0.01%). Specific values for known cross-reactants.Prednisolone: 29%11-Desoxy-Cortisol: 16%Corticosterone: 2.4%Cortisone: 3.3%Prednisone: 2.2%17α-OH-Progesterone: 1.2%Desoxy-Corticosterone: 0.5%6α-Methyl-17α-OH-Progesterone: 0.3%Other substances tested: < 0.01%
    Analytical Sensitivity (Limit of Detection)A low concentration indicating detection capability.0.015 µg/dL (Mean signal (Zero-Standard) - 2SD)
    Functional SensitivityConcentration with < 20% CV.0.060 µg/dL (Mean Conc. < 20 % CV)
    Precision (Intra-Assay & Inter-Assay)Low Coefficient of Variation (CV%) across different concentrations for both saliva and serum.Intra-Assay Saliva: 6.4% (0.252 µg/dL), 7.6% (0.312 µg/dL), 3.2% (2.927 µg/dL)Intra-Assay Serum: 11.8% (0.103 µg/dL), 10.7% (0.499 µg/dL), 3.8% (3.421 µg/dL)Inter-Assay Saliva: 9.1% (0.215 µg/dL), 6.9% (0.864 µg/dL), 6.2% (2.638 µg/dL)Inter-Assay Serum: 10.8% (0.094 µg/dL), 10.9% (0.394 µg/dL), 12.0% (0.582 µg/dL)
    LinearityPercent recovery (Rec. %) within an acceptable range across dilutions (e.g., 80-120%).Saliva: 83-114% (Sample 1), 95-115% (Sample 2), 84-114% (Sample 3) across various dilutions (1:2 to 1:32)Serum: 96-111% (Sample 1), 96-120% (Sample 2), 90-112% (Sample 3) across various dilutions (1:50 to 1:3200). Most values are within the 80-120% range.
    RecoveryPercent recovery (Rec. %) within an acceptable range (e.g., 80-120%).Saliva: 80-119% across three different saliva samples with varying added cortisol concentrations.Serum: 88-113% across three different serum samples with varying added cortisol concentrations. (Most values are within the 80-120% range and are considered acceptable.)

    2. Sample Sizes Used for the Test Set and Data Provenance

    • Method Comparison (vs. IBL-Luminescence IA):
      • Saliva: n = 130 samples
      • Serum: n = 129 samples
      • Data Provenance: Not explicitly stated, but the comparison is against the "Cortisol LIA" which is stated to be "manufactured in same way" as the original submission K052359 (and K010790). This implies a comparison against an existing, legally marketed device, likely using clinical samples. It's not specified if these were retrospective or prospective, nor the country of origin, beyond the manufacturer being in Germany.
    • Method Comparison (vs. GC/MS):
      • Serum: n = 33 samples
      • Data Provenance: Samples were obtained from the DGKC (Deutsche Gesellschaft für klinische Chemie, Bonn Germany) quality assessment scheme for hormones. This suggests a reference-based comparison using established samples. The method GC/MS is a recognized reference method.
    • Interference Studies: The number of unique samples for each interference test is not specified, but each interferent was tested at different cortisol concentrations (e.g., three cortisol levels for hemoglobin, bilirubin, triglyceride, thimerosal, NaN3, and two for blood).
    • Precision Studies:
      • Saliva: n = 20 for functional sensitivity and intra-assay/inter-assay precision.
      • Serum (1:50 diluted): n = 20 for functional sensitivity and intra-assay/inter-assay precision.
    • Linearity & Recovery Studies: The number of individual samples is not explicitly stated beyond "Saliva 1", "Saliva 2", "Saliva 3" (implies 3 unique saliva control/patient samples) and "Serum 1", "Serum 2", "Serum 3" (implies 3 unique serum control/patient samples), which were then diluted or spiked.

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

    • No human expert "ground truth" was established in the traditional sense for diagnostic interpretation. This device is a quantitative assay.
    • For method comparison: The ground truth was established by:
      • Quantitative results from an existing commercial device (IBL-Luminescence IA)
      • Quantitative results from a reference method (GC/MS, Siekmann et al., J.Clin.Chem.Clin.Biochem. 20 (1982) 883-892)
    • For other performance characteristics (sensitivity, specificity, precision, linearity, recovery): The ground truth is determined by the inherent properties of the samples (e.g., known spikes, dilutions, or intrinsic sample concentrations) and statistical calculations (e.g., means, standard deviations, CVs).

    4. Adjudication Method for the Test Set

    • Not applicable. This is a quantitative assay comparing its output to other quantitative methods or known sample properties, not relying on expert adjudication for a diagnostic classification.

    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

    • No. An MRMC study is not relevant for a quantitative diagnostic assay like this ELISA kit, which does not involve human interpretation of images or other subjective data.
    • The effectiveness is demonstrated by its analytical performance characteristics (accuracy, precision, linearity, etc.) and its correlation with established reference methods.

    6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

    • Yes. The performance studies presented are for the IBL Cortisol ELISA kit operating in a standalone capacity, without human-in-the-loop performance influencing the measurement itself. While a human operates the ELISA, the reported metrics reflect the assay's chemical and instrumental performance.

    7. The Type of Ground Truth Used

    • Quantitative Reference Methods: For method comparison, the ground truth was the quantitative concentration values obtained from:
      • IBL-Luminescence IA (a predicate device)
      • Gas Chromatography/Mass Spectrometry (GC/MS) (a recognized reference method and gold standard for some analytes)
    • Known Sample Properties: For precision, linearity, and recovery, the ground truth was based on:
      • Expected concentrations in control samples.
      • Calculated concentrations from known dilutions or spiking experiments.
    • Chemical Characteristics: For analytical sensitivity (LOD) and functional sensitivity, ground truth relates to the assay's intrinsic ability to detect and quantify low concentrations. For cross-reactivity, ground truth is the known concentration of interfering substances and their expected non-reactivity.

    8. The Sample Size for the Training Set

    • Not Applicable in the context of machine learning. This device is a traditional immunoassay kit, not an algorithm that requires a training set. Its "development" would involve optimizing reagents and protocols, not machine learning model training.

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

    • Not Applicable. See point 8.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1