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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.
 
DeviceDIMENSION TPSA FLEX REAGENT CARTRIDGE
Generic NamePROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
Regulation Number866.6010
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
500 GBC DRIVE
PO BOX 6101
NEWARK, DE 19714-6101
PMA NumberP000021
Supplement NumberS002
Date Received03/26/2002
Decision Date09/10/2002
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. THE DESIGN CHANGES INCLUDE MODIFICATION OF THE ASSAY RESPONSE TO PROVIDE EQUIVALENT RESULTS FOR SAMPLES WITH VARYING MIXTURES OF FREE PSA AND PSA-ACT AND OPTIMIZATION OF THE METHOD DESIGN TO MINIMIZE METHOD RESPONSE TO HUMAN ANTI-MURINE IMMUNOGLOBULIN ANTIBODIES AND HUMAN ANTI-BOVINE IMMUNOGLOBULIN ANTIBODIES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DIMENSION TPSA FLEX REAGENT CARTRIDGE AND IS INDICATED FOR: THE TPSA METHOD FOR THE DIMENSION CLINICAL CHEMISTRY SYSTEM WITH THE HETEROGENEOUS IMMUNOASSAY MODULE IS AN IN VITRO DIAGNOSTIC TEST INTENDED TO QUANTITATIVELY MEASURE TOTAL PROSTATE SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM AND PLASMA: 1) AS AN AID IN THE DETECTION OF PROSTATE CANCER WHEN USED IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) IN MEN 50 YEARS OR OLDER. PROSTATE BIOPSY IS REQUIRED FOR DIAGNOSIS OF CANCER 2) AS AN AID IN THE MANAGEMENT (MONITORING) OF PROSTATE CANCER PATIENTS.
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