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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 FPSA FLEX REAGENT CARTRIDGE
Generic NameTest, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
500 GBC DRIVE, P O BOX 6101
M/S 514
NEWARK, DE 19714-6101
PMA NumberP020027
Supplement NumberS001
Date Received09/29/2003
Decision Date10/10/2003
Product Code MTG 
Advisory Committee Immunology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL OF THE FOLLOWING MODIFICATIONS TO THE DIMENSION FPSA FLEX REAGENT CARTRIDGE: 1) ADDITION OF LITHIUM HEPARIN PLASMA AS A SAMPLE TYPE IN THE INTENDED USE AND THE PACKAGE LABELING. 2) ADDITION OF THE DISCLAIMER "RESULTS OF THIS TEST SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION AND OTHER FINDINGS" TO THE RESULTS SECTION OF THE PACKAGE LABELING. 3) CORRECTION OF THE UNITS FOR IGG IN THE PACKAGE LABELING FROM 6 G/ML TO 6 G/DL. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE SAME TRADE NAME, DIMENSION FPSA FLEX REAGENT CARTRIDGE AND IS INDICATED AS FOLLOWS: THE FPSA METHOD FOR THE DIMENSION CLINICAL CHEMISTRY SYSTEM WITH THE HETEROGENOUS IMMUNOASSAY MODULE IS AN IN VITRO DIAGNOSTIC TEST INTENDED TO QUANTITATIVELY MEASURE FREE PROSTATE SPECIFIC ANTIGEN (FPSA) IN HUMAN SERUM AND PLASMA. MEASUREMENTS OF FPSA ARE USED IN CONJUNCTION WITH TOTAL PSA (TPSA) ON THE DIMENSION SYSTEM TO CALCULATE FPSA TO TPSA RATIO EXPRESSED AS PERCENT FPSA. THE PERCENT FPSA IS USED AS AN AID IN DISTINGUISHING PROSTATE CANCER FROM BENIGN PROSTATE CONDITIONS IN MEN 50 YEARS OR OLDER WITH TPSA OF 4.0 TO 10/0 NG/ML (UG/L) AND DIGITAL RECTAL EXAMINATION (DRE) FINDINGS NOT SUSPICIOUS FOR CANCER. PROSTATE BIOPSY IS REQUIRED FOR DIAGNOSIS OF PROSTATE CANCER.
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