GENESEARCH BREAST LYMPH NODE(BLN) ASSAY
FDA premarket approval P060017 · decided 2007-07-16
Approval details
- PMA number
- P060017
- Trade name
- GENESEARCH BREAST LYMPH NODE(BLN) ASSAY
- Generic name
- RT-PCR multigene expression test, sentinel lymph node, cancer metastasis detection
- Applicant
- Janssen Diagnostics
- Date received
- 2006-05-01
- Decision date
- 2007-07-16
- Days to decision
- 441 days
- Decision code
- APWD
- Product code
- OCB
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Raritan, NJ
- 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 U
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