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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceIMMULITE 2500 PSA, IMMULITE 2500 THIRD GENERATION PSA
Generic NamePROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
Regulation Number866.6010
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS INC.
GLYN RHONWY, LLANBERIS
GWYNEDD LL55 4EL LL554
PMA NumberP930027
Supplement NumberS006
Date Received11/28/2003
Decision Date12/31/2003
Product Code LTJ 
Advisory Committee Immunology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE INTRODUCTION OF THE IMMULITE 2500 PSA AND IMMUITE 2500 THIRD GENERATION PSA TESTS FOR USE ON THE IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME IMMULITE 2500 PSA AND IMMULITE 2500 THIRD GENERATION PSA ASSAYS FOR THE FOLLOWING INDICATION: "THE IMMULITE 2500 PSA AND IMMUITE 2500 THIRD GENERATION PSA ASSAYS ARE FOR IN VITRO DIAGNOSTIC USE WITH THE IMMULITE 2500 ANALYZER FOR THE QUANTITATIVE MEASUREMENT OF PROSTATE-SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM, AS AN AID IN THE DETECTION OF PROSTATE CANCER WHEN USED IN CONJUNCTION WITH DIGITAL RECTAL EXAMINATION (DRE) IN MEN AGED 50 YEARS OR OLDER. EACH ASSAY IS FURTHER INDICATED AS AN ADJUNCTIVE TEST TO AID IN THE MANAGEMENT OF PROSTATE CANCER PATIENTS."
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