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510(k) Data Aggregation

    K Number
    K991371
    Device Name
    CARESIDE AMMONIA
    Manufacturer
    CARESIDE, INC.
    Date Cleared
    1999-08-03

    (105 days)

    Product Code
    JID, 75J
    Regulation Number
    862.1065
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    Product Code :

    JID

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For in vitro diagnostic use with the CARESIDE Analyzer™ to measure ammonia from anti-coagulated whole blood or plasma specimens to aid in the diagnosis and treatment of patients with severe liver disorders such as cirrhosis, hepatitis, and Reye's syndrome.
    Device Description
    CARESIDE™ Ammonia cartridges are used with the CARESIDE Analyzer™ to measure ammonia in anti-coagulated whole blood or plasma specimens. The CARESIDE™ Ammonia cartridge, a single use disposable in vitro diagnostic test cartridge, delivers a measured volume of plasma to a dry film to initiate the measurement of ammonia The film cartridge (patent pending) contains all reagents necessary to measure ammonia. Each CARESIDE™ Ammonia cartridge consists of an ammonia-specific multi-layer reagent film mounted in a plastic base with a hinged lid. The user introduces the specimen into the cartridge Sample Well, closes the lid and inserts the cartridge into the CARESIDE Analyzer™. Once loaded, the CARESIDE Analyzer™ scans the cartridge barcode, brings the cartridge and the contained specimen to 37°C, and spins the cartridge to move the sample from the Sample Well into the cartridge channels and chambers. 8.5 microliters of sample remains in the metering passage. Any excess sample flows into the Overflow Well. The 8.5 microliters of sample is automatically dispensed onto the multi-layer reagent film. The spreading layer distributes the sample evenly on the film before the sample moves through the reaction, porous, and detection layers where a blue-green dye forms in the presence of ammonia. The color intensity of the resulting blue-green dye, as measured by the amount of reflected light at 590 nanometers, directly relates to the ammonia concentration of the specimen. As the cartridges spin, a photodiode measures reflectance of light emitted by a wavelength-specific light emitting diode (LED) over a fixed time period. The analyzer uses the reflectance measurements and the lot-specific standard curve to calculate ammonia concentration.
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