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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceACCESS HYBRITECH P2PSA ON THE ACCESS IMMUNOASSAY SYSTEMS
Generic NameP2psa
ApplicantBECKMAN COULTER, INC.
1000 LAKE HAZELTINE DR.
CHASKA, MN 55318
PMA NumberP090026
Date Received11/17/2009
Decision Date06/14/2012
Product Code OYA 
Docket Number 12M-0638
Notice Date 06/20/2012
Advisory Committee Immunology
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
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.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S004 S005 S006 S007 S008 S009 S010 S011 S012 S013 
S014 S015 S016 S017 S018 S019 S021 S022 S023 S025 S026 S027 
S028 S029 S030 S031 
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