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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DevicePROGENSA PCA3 ASSAY
Generic NameProstrate cancer genes nucleic acid amplification test system
ApplicantGEN-PROBE INCORPORATED
10210 Genetic Center Drive
San Diego, CA 92121
PMA NumberP100033
Date Received08/10/2010
Decision Date02/13/2012
Withdrawal Date 04/12/2023
Product Code OYM 
Docket Number 12M-0173
Notice Date 03/06/2012
Advisory Committee Pathology
Clinical TrialsNCT01024959
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE PROGENSA PCA3 ASSAY. THIS DEVICE IS INDICATED FOR: PROGENSA PCA3 ASSAY IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST. THE ASSAY MEASURES THE CONCENTRATION OF PROSTATE CANCER GENE 3 (PCA3) AND PROSTATE-SPECIFIC ANTIGEN (PSA) RNA (RNA) MOLECULES AND CALCULATES THE RATIO OF PCA3 RNA MOLECULES TO PSA RNA MOLECULES (PCA3 SCORE) IN POST DIGITAL RECTAL EXAM (DRE) FIRST CATCH MALE URINE SPECIMENS. THE PROGENSA PCA3 ASSAY IS INDICATED FOR USE IN CONJUNCTION WITH OTHER PATIENT INFORMATION TO AID IN THE DECISION FOR REPEAT BIOPSY IN MEN 50 YEARS OF AGE OR OLDER WHO HAVE HAD ONE OR MORE PREVIOUS NEGATIVE PROSTATE BIOPSIES AND FOR WHOM A REPEAT BIOPSY WOULD BE RECOMMENDED BY A UROLOGIST BASED ON CURRENT STANDARD OF CARE, BEFORE CONSIDERATION OF PROGENSA PCA3 ASSAY RESULTS.A PCA3 SCORE <25 IS ASSOCIATED WITH A DECREASED LIKELIHOOD OF A POSITIVE BIOPSY. PROSTATIC BIOPSY IS REQUIRED FOR DIAGNOSIS OF CANCER.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 
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