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) | Registration & Listing | Adverse Events | Recalls | PMA | 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 record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET
Classification Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Generic Nameelectrochemiluminescence assay for the determination of prostate specific antigen;psa calibrator
ApplicantROCHE DIAGNOSTICS CORP.
PMA NumberP990056
Supplement NumberS003
Date Received02/13/2006
Decision Date08/10/2006
Product Code
MTF[ Registered Establishments with MTF ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for formulation change to the hama interference reduction proteins to improve assay robustness with regard to potential hama interference for the elecsys total psa immunoassay and changes in matrix, antigen and calibrator 1 target value for the elecsys total psa calset. The elecsys total psa calset, as modified, will be marketed under the trade name, elecsys total psa calset ii.
-
-