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510(k) Data Aggregation

    K Number
    K972024
    Device Name
    CODA AUTOMATED EIA ANALYZER
    Manufacturer
    Date Cleared
    1997-07-30

    (58 days)

    Product Code
    Regulation Number
    862.2500
    Why did this record match?
    Product Code :

    JJI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    CODA is an integrated immunoassay analyzer intended for the automation of microplate based assays for in vitro diagnostic use. The system is open, such that a variety of microplate-based enzyme immunoassays (EIA's) can be programmed and run on the instrument. The sample and reagent pipettes, incubator, washer, reader and robotics are housed in the compact benchtop unit. CODA Operation and Data Management software operates in the Windows 95 environment utilizing icon-based commands for operator ease of use.
    Device Description
    The Bio-Rad Coda Automated EIA Analyzer (Coda) is a compact, integrated immunoassay system designed for the automation of microplate based (8 wells by 12 strips) chemistries. The sampler, plate-shaker, incubator, washer, reader and robotics are housed in a single compact Main Unit. An external computer handles the operation and data management using software contained on a CD-ROM which operates in the Windows 95 environment. Enzyme immunoassay (EIA) typically involves the addition of a defined volume of sample to a series of plastic microtitre wells which have been pre-coated with antigen or antibody. The wells are sometimes washed to remove unbound ligand before addition of enzyme conjugate to each well. After incubation, substrate is added followed by a second incubation. The enzyme reaction is "stopped" and the colored reactant product is measured by absorbance at a defined wavelength. The absorbance values of the unknowns are compared to absorbance of calibrators to determine the concentration of the ligand in the sample. The Coda provides an integrated, automated approach to carrying out the above steps all under control of the computer and associated software. All the steps may be programmed into a complete protocol or individual steps may be performed in a manual mode. The Coda is therefore virtually usable with any assay kit using microtite plates. Output from the spectrophotometer is measured by the computer. Calculation, curve-fitting, result interpretation and other aspects of data management and analysis are automatically performed by the software algorithms.
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