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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 (CH)
    Reference & Predicate Devices
    K010790,K052359
    Why did this record match?
    Reference Devices :

    K010790

    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
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