|Approval Order Statement |
Approval for design changes to modify the composition and volumes of the reagents, and labeling changes to add claims for the use of lithium and nh4-heparin plasma samples, to eliminate the recommendation for na citrate plasma, and to omit the sample dilution claim. The device, as modified, will be marketed under the trade name elecsys free psa immunoassay and is indicated 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 assay 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 prostatic 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 ng/ml to 10 ng/ml. Prostate biopsy is required for the diagnosis of prostate cancer. The electrochemilumi-niscence immunoassay "eclia" is intended for use on the roche diagnostics elecsys 1010 and 2010, and the modular analytics e170 immunoassay analyzers.