System, Test, Her-2/Neu, Ihc
Basic Information
- Device Name
- System, Test, Her-2/Neu, Ihc
- Trade Name
- INSITE HER-2/NEU KIT
- PMA Number
- P040030
- Device Class
- FDA Class 3
- Product Code
- MVC
- Generic Name
- SYSTEM, TEST, HER-2/NEU, IHC
- Medical Specialty
- Unknown
- Advisory Committee
- Pathology
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- December 22, 2004
- Date Received
- June 22, 2004
- Expedited Review
- N
- Docket Number
- 05M-0160
Advisory Committee Statement
APPROVAL FOR THE INSITE HER-2/NEU KIT. THE DEVICE IS INDICATED FOR: INSITE HER-2/NEU MOUSE MONOCLONAL ANTIBODY (CLONE CB11) KIT IS INTENDED FOR IN VITRO DIAGNOSTIC USE IN IMMUNOHISTOCHEM-ISTRY (IHC) ASSAYS TO SEMI-QUANTITATIVELY LOCALIZED BY LIGHT MICROSCOPY THE OVER-EXPRESSION OF HER-2/NEU (I.E., C-ERBB-2) IN FORMALIN-FIXED, PARAFFIN-EMBEDDED NORMAL AND NEOPLASTIC TISSUE SECTIONS. INSITE HER-2/NEU IS INDICATED AS AN AID IN THE ASSESSMENT OF BREAST CANCER PATIENTS FOR WHOM HERCEPTIN (TRASTUZUMAB) THERAPY IS BEING CONSIDERED. CLINICAL INTERPRETATION OF INSITE HER-2/NEU IMMUNOSTAINING RESULTS (ABSENCE OR PRESENCE; SEMI-QUANTITATIVE INTENSITY SCORE) SHOULD BE COMPLEMENTED BY APPROPRIATE CONTROLS AND MORPHOLOGICAL TISSUE ANALYSIS AND BE EVALUATED BY A QUALIFIED PATHOLOGIST WITHIN THE CONTEXT OF PATIENT CLINICAL HISTORY AND OTHER DIAGNOSTIC RESULTS.
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 |