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510(k) Data Aggregation

    K Number
    K142994
    Device Name
    IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers
    Manufacturer
    IMMUNODIAGNOSTIC SYSTEMS LTD.
    Date Cleared
    2015-04-21

    (187 days)

    Product Code
    CJM, JJX
    Regulation Number
    862.1045
    Why did this record match?
    Product Code :

    CJM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IDS-iSYS Aldosterone assay (IS-3300) is a device intended for use in clinical laboratories for the quantitative determination of Aldosterone in human EDTA plasma on the IDS-iSYS Multi-Discipline Automated System. Aldosterone measurements are used in the diagnosis and treatment of primary aldosteronism (a disorder caused by excessive secretion of Aldosterone by the adrenal gland), hypertension caused by primary aldosteronism, selective hyperaldosteronism, edematous states and other conditions of electrolyte balance. The IDS-iSYS Aldosterone Control Set (IS-3330) is intended for use as assaved quality control samples to monitor the accuracy of the IDS-iSYS Aldosterone assay on the IDS-iSYS Multi-Discipline Automated System. The IDS-iSYS Aldosterone Calibration Verifiers (IS-3335) are intended for medical purposes for use in the quantitative verification of calibration of the IDS-iSYS Aldosterone assay on the IDS-iSYS Multi-Discipline Automated System.
    Device Description
    The IDS-iSYS Aldosterone assay is based on chemiluminescence technology. A biotinylated monoclonal anti-Aldosterone antibody is incubated with the sample, after an incubation step an Aldosterone acridinium conjugate is added and after a further incubation step streptavidin coated magnetic particles are added. Following a third incubation step the particles are "captured" using a magnet. After a washing step and addition of trigger reagents, the light emitted by the acridinium label is inversely proportional to the concentration of Aldosterone in the original sample.
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    K Number
    K130321
    Device Name
    LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERS
    Manufacturer
    DIASORIN
    Date Cleared
    2013-04-09

    (60 days)

    Product Code
    CJM, JJX, PRE
    Regulation Number
    862.1045
    Why did this record match?
    Product Code :

    CJM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LIAISON® Aldosterone assay uses chemiluminescent immunoassay (CLIA) technology and is intended for the quantitative determination of Aldosterone in human serum. EDTA plasma and treated urine samples. Aldosterone measurements are intended for use in the diagnosis and treatment of primary aldosteronism (a disorder caused by excessive secretion of aldosterone by the adrenal gland), hypertension caused by primary aldosteronism, selective hypoaldosteronism, edematous states and other conditions of electrolyte imbalance. The test has to be performed on the LIAISON® Analyzer. The DiaSorin LIAISON® Aldosterone Control Set is intended for use as assayed quality control samples to monitor the accuracy of the DiaSorin LIAISON® Aldosterone assay on the LIAISON® Analyzer. The DiaSorin LIAISON® Aldosterone Calibration Verifiers are assayed quality control materials intended for the quantitative verification of calibration and reportable range of the LIAISON® Aldosterone assay when performed on the LIAISON® Analyzer.
    Device Description
    The LIAISON® Aldosterone assay is a competitive modified 2 step chemiluminescent assay that uses sheep monoclonal antibody for capture of the Aldosterone molecule. Results are determined by a 2 point calibration conversion of the master curve to a working curve. The light signal is measured by a photomultiplier as relative light units (RLU) and is inversely proportional to the concentration of aldosterone present in the calibrators, controls or samples.
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    K Number
    K050784
    Device Name
    NICHOLS ADVANTAGE ALDOSTERONE ASSAY
    Manufacturer
    NICHOLS INSTITUTE DIAGNOSTICS
    Date Cleared
    2005-06-01

    (65 days)

    Product Code
    CJM, CLI
    Regulation Number
    862.1045
    Why did this record match?
    Product Code :

    CJM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nichols Advantage Aldosterone Assay is intended for in vitro diagnostic laboratory use with the Nichols Advantage® Specialty System for quantitative measurement of aldosterone in human serum, EDTA plasma, and extracted urine. Aldosterone measurements are intended for use in the diagnosis and treatment of primary aldosteronism (a disorder caused by excessive secretion of aldosterone by the adrenal gland), hypertension caused by primary aldosteronism, selective hypoaldosteronism, edematous states, and other conditions of electrolyte imbalance.
    Device Description
    The Nichols Advantage® Aldosterone Assay is a competitive immunochemiluminometric in vitro diagnostic laboratory immunoassay (IVD device) that utilizes a biotinylated mouse monoclonal anti-aldosterone antibody as the capture reagent and an acridinium ester labeled aldosterone as a tracer reagent. This Aldosterone IVD device immunoassay is intended for use for the measurement of aldosterone in human serum, EDTA plasma, and extracted urine, as an extended diagnostic method utilized within the Nichols Advantage® Specialty System.
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    K Number
    K032188
    Device Name
    NICHOLS ADVANTAGE ALDOSTERONE ASSAY
    Manufacturer
    NICHOLS INSTITUTE DIAGNOSTICS
    Date Cleared
    2003-07-31

    (14 days)

    Product Code
    CJM, JIS, JJX
    Regulation Number
    862.1045
    Why did this record match?
    Product Code :

    CJM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nichols Advantage® Aldosterone assay is intended for use with the Nichols Advantage® Specialty System to quantitatively measure aldosterone in human serum and EDTA plasma. Aldosterone measurements are used in the diagnosis and treatment of primary aldosteronism (a disorder caused by excessive secretion of aldosterone by the adrenal gland), hypertension caused by primary aldosteronism, selective hypoaldosteronism, edematous states, and other conditions of electrolyte imbalance.
    Device Description
    The Nichols Advantage® Aldosterone assay contains sufficient reagents for 100 tests. The assay is a competitive binding assay for aldosterone in human serum or plasma.
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