Access Hybritech P2PSA on the Access Immunoassay Systems

Approval order statement

APPROVAL FOR THE ACCESS HYBRITECH P2PSA ON THE ACCESS IMMUNOASSAY SYSTEMS. THIS DEVICE IS INDICATED FOR: THE ACCESS HYBRITECH P2PSA ASSAY IS A PARAMAGNETIC PARTICLE, CHEMILUMINESCENT IMMUNOASSAY FOR THE QUANTITATIVE DETERMINATION OF [-2]PROPSA ANTIGEN, AN ISOFORM OF FREEPSA, IN HUMAN SERUM USING THE ACCESS IMMUNOASSAY SYSTEMS. ACCESS HYBRITECH P2PSA IS INTENDED TO BE USED IN COMBINATION WITH ACCESS HYBRITECH (TOTAL) PSA AND ACCESS HYBRITECH FREE PSA TO CALCULATE THE BECKMAN COULTER PROSTATE HEALTH INDEX (PHI), AN IN VITRO DIAGNOSTIC MULTIVARIATE INDEX ASSAY (IVDMIA). BECKMAN COULTER PHI AS CALCULATED USING THE ACCESS HYBRITECH ASSAYS IS INDICATED FOR USE ASAN AID IN DISTINGUISHING PROSTATE CANCER FROM BENIGN PROSTATIC CONDITIONS, FOR PROSTATE CANCER DETECTION IN MEN AGED 50 YEARS AND OLDER WITH TOTAL PSA >= 4.0 TO <= 10.0 NG/ML, AND WITH DIGITAL RECTAL EXAMINATION FINDINGS THAT ARE NOT SUSPICIOUS FOR CANCER. PROSTATIC BIOPSYIS REQUIRED FOR DIAGNOSIS OF CANCER.