Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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.
 
DeviceBAYER IMMUNO 1 COMPLEXED PSA ASSAY
Generic NameANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
333 CONEY STREET
WALPOLE, MA 02032-1516
PMA NumberP990055
Date Received10/01/1999
Decision Date09/08/2000
Product Code NAF 
Docket Number 00M-1524
Notice Date 09/26/2000
Advisory Committee Immunology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE BAYER IMMUNO 1(TM) COMPLEXED PSA ASSAY. THE IN VITRO DEVICE IS INTENDED TO QUANTITATIVELY MEASURE COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) IN HUMAN SERUM ON THE BAYER IMMUNO 1(TM) SYSTEM. THIS DEVICE IS INDICATED FOR THE MEASUREMENT OF SERUM COMPLEXED PSA IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) AS AN AID IN THE DETECTION OF PROSTATE CANCER IN MEN AGED 50 YEARS OR OLDER. BIOPSY OF THE PROSTATE IS REQUIRED FOR THE DIAGNOSIS OF PROSTATE CANCER. THIS DEVICE IS FURTHER INDICATED AS AN AID IN THE MANAGEMENT (MONITORING) OF PROSTATE CANCER PATIENTS. THIS DIAGNOSTIC METHOD IS NOT INTENDED FOR USE ON ANY OTHER SYSTEM.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S014 S015 S001 S012 S010 S011 S007 S004 S005 S006 S008 
S009 S002 S003 S013 S020 S021 S023 S024 S017 S016 S018 S019 
S022 S025 S026 
-
-