System, Test, Her-2/Neu, Ihc
Basic Information
- Device Name
- System, Test, Her-2/Neu, Ihc
- Trade Name
- HERCEP TEST
- PMA Number
- P980018
- Supplement Number
- S015
- Device Class
- FDA Class 3
- Product Code
- MVC
- Generic Name
- SYSTEM, TEST, HER-2/NEU, IHC
- 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 HERCEPTEST. THEDEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HERCEPTEST AND ITS INDICATION FOR USE IS: HERCEPTEST IS A SEMI-QUANTITATIVE IMMUNOHISTO-CHEMICAL ASSAY TO DETERMINE HER2 PROTEIN OVEREXPRESSION IN BREAST CANCER TISSUES ROUTINELY PROCESSED FOR HISTOLOGICAL EVALUATION AND FORMALIN-FIXED, PARAFFIN-EMBEDDED CANCER TISSUE FROM PATIENTS WITH METASTATIC GASTRIC OR GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA. HERCEPTEST 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 BEINGCONSIDERED (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 |
|---|---|---|---|
| MVC | System, Test, Her-2/Neu, Ihc | FDA class 3 | Unknown |