Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer
Basic Information
- Device Name
- Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer
- Trade Name
- SPOT-LIGHT HER2 CISH KIT
- PMA Number
- P050040
- Device Class
- FDA Class 3
- Product Code
- NYQ
- Generic Name
- Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
- Medical Specialty
- Unknown
- Advisory Committee
- Pathology
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- July 1, 2008
- Date Received
- November 3, 2005
- Expedited Review
- N
- Docket Number
- 08M-0437
Advisory Committee Statement
APPROVAL FOR SPOT-LIGHT HER2 CISH KIT. THIS DEVICE IS INDICATED FOR: THE SPOT-LIGHT HER2 CISH KIT IS INTENDED TO QUANTITATIVELY DETERMINE HER2 GENE AMPLIFICATION IN FORMALIN-FIXED, PARAFFIN-EMBEDDED (FFPE) BREAST CARCINOMA TISSUE SECTIONS USING CHROMOGENIC IN SITU HYBRIDIZATION (CISH) AND BRIGHTFIELD MICROSCOPY. THIS TEST SHOULD BE PERFORMED IN A HISTOPATHOLOGY LABORATORY. THE SPOT-LIGHT HER2 CISH KIT IS INDICATED AS AN AID IN THE ASSESSMENT OF PATIENTS FOR WHOM HERCEPTIN (TRASTUZUMAB) TREATMENT IS BEING CONSIDERED. THE ASSAY RESULTS ARE INTENDED FOR USE AS AN ADJUNCT TO THE CLINICOPATHOLOGICAL INFORMATION CURRENTLY BEING USED AS PART OF THE MANAGEMENT OF BREAST CANCER PATIENTS. INTERPRETATION OF TEST RESULTS MUST BE MADE WITHIN THE CONTEXT OF THE PATIENT'S CLINICAL HISTORY BY A QUALIFIED PATHOLOGIST.
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 |
|---|---|---|---|
| NYQ | Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer | FDA class 3 | Unknown |