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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.
 
DeviceGENESEARCH BREAST LYMPH NODE(BLN) ASSAY
Generic NameRT-PCR multigene expression test, sentinel lymph node, cancer metastasis detection
ApplicantJANSSEN DIAGNOSTICS
700 US HIGHWAY RTE 202 SOUTH
RARITAN, NJ 08869
PMA NumberP060017
Date Received05/01/2006
Decision Date07/16/2007
Withdrawal Date 03/30/2015
Product Code OCB 
Docket Number 07M-0413
Notice Date 11/09/2007
Advisory Committee Pathology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE GENESEARCH BREAST LYMPH NODE (BLN) ASSAY. THIS DEVICE IS INDICATED AS A QUALITATIVE, IN VITRO DIAGNOSTIC TEST FOR THE RAPID DETECTION OF GREATER THAN 0.2 MM METASTASES IN NODAL TISSUE REMOVED FROM SENTINEL LYMPH NODE BIOPSIES OF BREAST CANCER PATIENTS. RESULTS FROM THE ASSAY CAN BE USED TO GUIDE THE INTRA OPERATIVE OR POST-OPERATIVE DECISION TO REMOVE ADDITIONAL LYMPH NODES. POST-OPERATIVE HISTOLOGICAL EVALUATION OF PERMANENT SECTIONS OF THE TISSUE SPECIMEN, IN ACCORDANCE WITH USUAL DIAGNOSTIC PRACTICE AND USING THE VERIDEX LYMPH NODE CUTTING SCHEME, IS REQUIRED.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S003 S004 
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