System, Test, Her-2/Neu, Nucleic Acid Or Serum
Basic Information
- Device Name
- System, Test, Her-2/Neu, Nucleic Acid Or Serum
- Trade Name
- HER2 FISH PHARMADX KIT
- PMA Number
- P040005
- Supplement Number
- S006
- 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
- June 8, 2012
- Date Received
- December 5, 2011
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR ADDITION OF PERTUZUMAB IN THE LABELING OF HER2 FISH PHARMDX KIT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HER2 FISH PHARMDX KIT AND ITS INDICATION FOR USE IS: A DIRECT FLUORESCENCE IN SITU HYBRIDIZATION (FISH) ASSAY DESIGNED TOQUANTITATIVELY DETERMINE HER2 GENE AMPLIFICATION IN FORMALIN-FIXED, PARAFFIN-EMBEDDED (FFPE) BREAST CANCER TISSUE SPECIMENS AND FFPE SPECIMENS FROM PATIENTS WITH METASTATIC GASTRIC OR GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA. HER2 FISH PHARMDX KIT IS INDICATED AS AN AID IN THE ASSESSMENT OF BREAST AND GASTRIC CANCER PATIENTS FOR WHOM HERCEPTIN (TRASTUZUMAB) TREATMENT IS BEING CONSIDERED AND FOR BREAST CANCER PATIENTS FOR WHOM PERJETA (PERTUZUMAB) TREATMENT IS BEING CONSIDERED (SEE HERCEPTIN AND PERJETA PACKAGE INSERTS).
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 |