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510(k) Data Aggregation

    K Number
    K242505
    Device Name
    Elecsys Cortisol III
    Manufacturer
    Roche Diagnostics
    Date Cleared
    2025-07-17

    (329 days)

    Product Code
    JFT
    Regulation Number
    862.1205
    Why did this record match?
    Product Code :

    JFT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K192788
    Device Name
    ADVIA Centaur Cortisol (COR)
    Manufacturer
    Siemens Healthcare Diagnostics, Inc.
    Date Cleared
    2019-11-25

    (56 days)

    Product Code
    JFT
    Regulation Number
    862.1205
    Why did this record match?
    Product Code :

    JFT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For in vitro diagnostic use in the quantitative determination of cortisol in serum, plasma (EDTA and lithium heparin), and urine using the ADVIA Centaur® XP system. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.
    Device Description
    The ADVIA Centaur Cortisol (COR) assay is a competitive immunoassay using direct chemiluminescent technology. Results are determined using a calibration curve that is generated specifically on each instrument by a 2-point calibration and a master curve with the reagent bar code. The ADVIA Centaur Cortisol (COR) assay is intended for use on the ADVIA Centaur family of analyzers. The ADVIA Centaur Calibrator E is a set of 2 level calibrators for the assay. Siemens recommends the use of commercially available quality control materials with at least two levels (low and high).
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    K Number
    K152227
    Device Name
    Elecsys Cortisol II, Cortisol II CalSet
    Manufacturer
    ROCHE DIAGNOSTICS
    Date Cleared
    2016-04-27

    (264 days)

    Product Code
    JFT, JIT
    Regulation Number
    862.1205
    Why did this record match?
    Product Code :

    JFT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Immunoassay for the in vitro quantitative determination of cortisol in human serum, and plasma. The determination of cortisol is used for the recognition and treatment of functional disorders of the adrenal gland. The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers. Cortisol II CalSet is used for calibrating the quantitative Elecsys Cortisol II assay on the Elecsys and cobas e immunoassay analyzers.
    Device Description
    The Elecsys Cortisol II assay makes use of a competition test principle using a monoclonal antibody which is specifically directed against cortisol. Endogenous cortisol which has been liberated from binding proteins with danazol competes with exogenous cortisol derivative in the test which has been labeled with ruthenium complex for the binding sites on the biotinylated antibody. Results are determined via a calibration curve which is instrument specifically generated by 2point calibration and a master curve provided via reagent barcode. The reagent working solutions include: - rackpack (kit placed on instrument) . - Streptavidin coated microparticles, ş - Reagent 1 (Anti-cortisol-Ab~biotin) and ş - Reagent 2 (Cortisol-peptide~Ru(bpy)2+3). ş The Cortisol II CalSet is a lyophilized human serum with added cortisol in two concentration ranges. The CalSet includes: - Cal 1 (approximately 12.5 nmol/L cortisol in a human serum matrix) . - Cal 2 (approximately 1000 nmol/L cortisol in a human serum matrix) .
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    K Number
    K142723
    Device Name
    ADVIA Centaur Cortisol (COR) Assy
    Manufacturer
    Siemens Healthcare Diagnostics Inc.
    Date Cleared
    2015-03-31

    (189 days)

    Product Code
    JFT
    Regulation Number
    862.1205
    Why did this record match?
    Product Code :

    JFT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ADVIA Centaur® Cortisol (COR) Assay is for in vitro diagnostic use in the quantitative determination of cortisol in serum or urine using the ADVIA Centaur XP system. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.
    Device Description
    The ADVIA Centaur Cortisol assay is a competitive immunoassay using direct chemiluminescent technology. Results are determined using a calibration curve that is generated specifically on each instrument by a 2-point calibration and a master curve with the reagent bar code. The ADVIA Centaur Cortisol Assay is intended for use on the ADVIA Centaur Family of analyzers. The ADVIA Centaur Calibrator E is a set of 2 level calibrators for the assay. Siemens recommends the use of commercially available quality control materials with at least two levels (low and high).
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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
    Why did this record match?
    Product Code :

    JFT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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®.
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    K Number
    K033731
    Device Name
    AXSYM CORTISOL ASSAY
    Manufacturer
    FUJIREBIO DIAGNOSTICS, INC.
    Date Cleared
    2004-02-20

    (84 days)

    Product Code
    JFT, JIT, JJX
    Regulation Number
    862.1205
    Why did this record match?
    Product Code :

    JFT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AxSYM® Cortisol assay is a Fluorescence Polarization Immunoassay (FPIA) for the quantitative measurement of Cortisol in human serum, plasma or urine on the AxSYM® System to aid in the diagnosis and treatment of adrenal disorders.
    Device Description
    The AxSYM Cortisol assay utilizes Fluorescence Polarization Immunoassay (FPIA) technology. The AxSYM Cortisol Reagents and sample are pipetted in the following sequence: - Sample and all AxSYM Cortisol Reagents required for one test are pipetted by the sampling probe into various positions of a Reaction Vessel (RV). - Sample, the Cortisol Antiserum (antibody), pretreatment solution and Solution 4 (Line Diluent) are pipetted into one well of the RV. - Additional pretreatment solution 4 (Line Diluent) are pipetted to the cuvette of the RV. - The RV is immediately transferred into the Processing Center. Further pipetting is done in the Processing Center by the Processing Probe. In the processing center, an aliquot of the predilution mixture and Solution 4 (Line Diluent) are transferred to the cuvette of the RV and the blank intensity of the sample is measured. A second aliquot of the predilution mixture is transferred to the cuvette along with the Cortisol Fluorescein Tracer. Cortisol from the sample and the Cortisol Fluorescein Tracer compete for binding sites on the antibody molecule. The intensity of polarized fluorescent light is measured by the FPIA optical assembly.
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    K Number
    K021218
    Device Name
    ELECSYS CORTISOL TEST SYSTEM
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Date Cleared
    2002-09-09

    (145 days)

    Product Code
    JFT
    Regulation Number
    862.1205
    Why did this record match?
    Product Code :

    JFT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Immunological in vitro assay for the quantitative determination of cortisol in human serum, plasma and urine. The determination of cortisol is used for the recognition and treatment of functional disorders of the adrenal gland. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys® 1010 / 2010 and Modular Analytics E170 (Elecsys module) Immunoassay Analyzers.
    Device Description
    The ELECSYS® Cortisol Assay a two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2-point calibration and a master curve provided with the reagent bar code.
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    K Number
    K962559
    Device Name
    ACS CORTISOL IMMUNOASSAY
    Manufacturer
    CIBA CORNING DIAGNOSTICS CORP.
    Date Cleared
    1996-11-05

    (127 days)

    Product Code
    JFT
    Regulation Number
    862.1205
    Why did this record match?
    Product Code :

    JFT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the quantitative determination of cortisol in serum using the Ciba Corning Automated Chemiluminescence Systems.
    Device Description
    The Ciba Corning ACS Cortisol assay is a competitive chemiluminescent immunoassay. Cortisol in the patient sample competes with the acridinium ester (AE-labeled cortisol (Lite Reagent) for binding to polyclonal rabbit anti-cortisol antibody on the Solid Phase. The polyclonal rabbit anti-cortisol antibody is bound to monoclonal mouse anti-rabbit antibody, which is coupled to paramagnetic particles (solid phase). An inverse relationship exists between the amount of cortisol present in the patient sample and the amount of relative light units (RLUs) detected by the ACS:180® system.
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