|Trade Name||ELSECSYS FREE PSA IMMUNOASSAY,FREE PSA CALSET,FREE PSA CALCHECK|
|Classification Name||prostate-specific antigen (psa) for management of prostate cancers|
|Applicant||ROCHE DIAGNOSTICS CORP.|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the addition of the elecsys free psa assay to the modular analytics e170 immunoassay analyzer. The device, as modified, will be marketed under the trade name elecsys free psa immunoassay, elecsys free psa calset and elecsys free psa calcheck and are indicated as follows: immunoassay for the in vitro quantitative determination of free prostate-specific antigen in human serum and plasma. The elecsys free psa immunoassay is indicated for measurement of fpsa in conjunction with the elecsys total psa to develop a ratio (% fpsa) of fpsa to tpsa. This ratio is useful when used in conjunction with the elecsys total psa test as an aid in distinguishing prostate cancer from benign prostate conditions in men age 50 years or older who have a digital rectal examination (dre) that is not suspicious for prostate cancer and an elecsys total psa value in the range 4-10ng/ml. Prostate biopsy is required for the diagnosis of prostate cancer. The electrochemilumi-nescence immunoassay "eclia" is intended for use on the roche elecsys 1010/2010 and modular analytics e170 (elecsys module) immunoassay analyzers. Elecsys free psa calset is used for calibrating the quantitative elecsys free psa assay on the elecsys 1010/2010 and modular analytics e170 immunoassay systems. Free psa calcheck is for use in the verification of the calibration established by the elecsys free psa reagent on elecsys 1010/2010 and modular analytics e170 immunoassay analyzers.