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 record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceST AIA-PACK PA
Generic NamePROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
Regulation Number866.6010
ApplicantTOSOH BIOSCIENCE, INC.
6000 SHORELINE COURT
SUITE 101
SOUTH SAN FRANCISCO, CA 94080
PMA NumberP910065
Supplement NumberS004
Date Received06/04/2003
Decision Date08/12/2003
Product Code LTJ 
Advisory Committee Immunology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR DESIGN CHANGES TO INCLUDE REDUCTION OF THE INCUBATION TIME FROM 40 TO 10 MINUTES, CHANGE IN THE CONJUGATE DILUENT, DECREASE IN ALP ACTIVITY AND CHANGE IN PACKAGING SIZE FROM 200 TESTS TO 100 TESTS PER BOX. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ST AIA-PACK PA AND IS INDICATED FOR: ST AIA-PACK PA IS DESIGNED FOR IN VITRO DIAGNOSTIC USE ONLY FOR THE QUANTITATIVE MEASUREMENT OF PROSTATE SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM ON TOSOH AIA NEX*IA AND TOSOH AIA-600 II ANALYZERS. THIS DEVICE IS INDICATED FOR THE MEASUREMENT OF SERUM PSA IN CONJUNCTION WITH DIGITAL RECTAL EXAMINATION (DRE) AS AN AID IN THE DETECTION OF PROSTATE CANCER (CAP) IN MEN FIFTY YEARS OF AGE AND OLDER. PROSTATE BIOPSY IS REQUIRED FOR THE DIAGNOSIS OF CANCER. THE DEVICE IS FURTHER INDICATED FOR THE SERIAL MEASUREMENT OF PSA IN HUMAN SERUM TO BE USED AS AN AID IN THE MANAGEMENT OF PATIENTS WITH PROSTATIC CANCER.
-
-