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510(k) Data Aggregation

    K Number
    K112161
    Device Name
    AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE..
    Manufacturer
    RADIOMETER MEDICAL APS
    Date Cleared
    2012-01-20

    (177 days)

    Product Code
    KHO, DDR, JIT, JJY
    Regulation Number
    862.2560
    Why did this record match?
    Product Code :

    KHO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AQT90 FLEX analyzer is for in vitro diagnostic use. The instrument is an immunoassay instrument based on the quantitative determination of time-resolved fluorescence to estimate the concentrations of clinically relevant markers on whole-blood and plasma specimens to which a relevant anticoagulant has been added. It is intended for use in point-of-care and laboratory settings. AQT90 FLEX Myo Test is an in vitro diagnostic assay for the quantitative determination of myoglobin in EDTA or lithium-heparin whole blood or plasma specimens on the AQT90 FLEX analyzer in point of care and laboratory settings. It is indicated for use as an aid in the rapid diagnosis of heart disease, e.g. acute myocardial infarction. AOT90 FLEX Myo CAL cartridge is for in vitro diagnostic use. For calibration adjustment of the Myo Test, as indicated on the cartridge, on the AQT90 FLEX analyzer. AQT90 FLEX LQC Multi-CHECK, Levels 1-3, is for in vitro diagnostic use. For use with the AQT90 FLEX analyzer as a liquid quality control serum (LQC) to monitor the precision of laboratory testing procedures for the analytes listed on the specification insert.
    Device Description
    The AOT90 FLEX is a cartridge-based immunoassay, based on time-resolved fluorescence using a europium (Eu) chelate as the fluorescent label. The test receptacles for the assay are 300 µL test cups, which contain the antibodies used for capture of the analyte, and the Eu chelate labeled antibodies used to trace the captured analyte. The sample is added to the test cup together with assay buffer. The cup is then incubated to allow formation of the immuno-complex, and subsequently washed to remove unbound antibodies and sample material. Finally, the cup is exposed to excitation light, and after a delay the emitted light generated by the fluorescent label is measured by single photon counting; this measurement cycle is repeated up to 3,300 times. The total count is then compared to an assay calibration curve to obtain a quantitative measurement of the analyte's concentration in the sample. This technology uses dried reagents deposited in the test cups and in the calibration adjustment cups - no liquids other than the sample itself together with the assay buffer are required. Total assay time is less than 20 minutes.
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    K Number
    K973547
    Device Name
    TRIAGE STATMETER
    Manufacturer
    BIOSITE INCORPORATED
    Date Cleared
    1998-01-13

    (117 days)

    Product Code
    KHO, DDR, JHX, MMI
    Regulation Number
    862.2560
    Why did this record match?
    Product Code :

    KHO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fluometer for the measurement of fluorescence in various assay systems. General fluorometer.
    Device Description
    Not Found
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    K Number
    K971103
    Device Name
    AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM
    Manufacturer
    TOSOH MEDICS, INC.
    Date Cleared
    1997-06-27

    (93 days)

    Product Code
    KHO
    Regulation Number
    862.2560
    Why did this record match?
    Product Code :

    KHO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AIA NexIA Automated Enzyme Immunoassay System is a combination device, utilizing a fluorometer and automated pipettor, intended for clinical use. The NexlA is used in conjunction with the AIA-PACK reagent series to measure a variety of analytes in biological fluids which aid in the diagnosis and treatment of various disorders.
    Device Description
    The AIA NexIA Automated Enzyme Immunoassay System is a combination device, utilizing a fluorometer and automated pipettor, intended for clinical use.
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    K Number
    K962919
    Device Name
    VITROS IMMUNODIAGNOSTIC SYSTEM
    Manufacturer
    JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
    Date Cleared
    1996-10-18

    (84 days)

    Product Code
    KHO
    Regulation Number
    862.2560
    Why did this record match?
    Product Code :

    KHO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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