System, Test, Her-2/Neu, Nucleic Acid Or Serum
Basic Information
- Device Name
- System, Test, Her-2/Neu, Nucleic Acid Or Serum
- Trade Name
- PATHVYSION HER-2 DNA PROBE KIT
- PMA Number
- P980024
- Supplement Number
- S001
- Device Class
- FDA Class 3
- Product Code
- MVD
- Generic Name
- SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
- Medical Specialty
- Unknown
- Advisory Committee
- Pathology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- December 31, 2001
- Date Received
- March 30, 2001
- Supplement Type
- Panel Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
- Docket Number
- 02M-0172
Advisory Committee Statement
APPROVAL FOR THE PATHVYSION HER-2 DNA PROBE KIT. THIS DEVICE IS INDICATED TO DETECT AMPLIFICATION OF THE HER-2/NEU GENE VIA FLUORESCENCE IN SITU HYBRIDIZATION (FISH) IN FORMALIN-FIXED, PARAFFIN-EMBEDDED HUMAN BREAST CANCER TISSUE SPECIMENS. RESULTS FROM THE PATHVYSION KIT ARE INTENDED FOR USE AS AN ADJUNCT TO EXISTING CLINICAL AND PATHOLOGIC INFORMATION CURRENTLY USED AS PROGNOSTIC FACTORS IN STAGE II, NODE-POSITIVE BREAST CANCER PATIENTS. THE PATHVYSION KIT IS FURTHER INDICATED AS AN AID TO PREDICT DISEASE-FREE AND OVERALL SURVIVAL IN PATIENTS WITH STAGE II, NODE POSITIVE BREAST CANCER TREATED WITH ADJUVANT CYCLOPHOSPHAMIDE, DOXORUBICIN, AND 5-FLUOROURACIL (CAF) CHEMOTHERAPY. THE PATHVYSION KIT IS INDICATED AS AN AID IN THE ASSESSMENT OF PATIENTS FOR WHOM HERCEPTIN (TRASTUZUMAB) TREATMENT IS BEING CONSIDERED (SEE HERCEPTIN PACKAGE INSERT).
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MVD | System, Test, Her-2/Neu, Nucleic Acid Or Serum | FDA class 3 | Unknown |