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
- HER2 CISH PHARMDX KIT
- PMA Number
- P100024
- 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- Approved (Withdrawn)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
- November 30, 2011
- Date Received
- June 21, 2010
- Expedited Review
- N
- Docket Number
- 11M-0866
Advisory Committee Statement
APPROVAL FOR THE HER2 CISH PHARMDX KIT. THIS DEVICE IS INDICATED TOR;HER2 CISH PHARMDX KIT IS INTENDED FOR DUAL-COLOR CHROMOGENIC VISUALIZATION OF SIGNALS ACHIEVED WITH DIRECTLY LABELED IN SITU HYBRIDIZATION PROBES TARGETING THE HER2 GENE AND CENTROMERIC REGION OF CHROMOSOME 17. THE KIT IS DESIGNED TO QUANTITATIVELY DETERMINE HER2 GENE STATUS IN FORMALIN-FIXED, PARAFFIN-EMBEDDED BREAST CANCER TISSUE SPECIMENS. RED AND BLUE CHROMOGENIC SIGNALS ARE GENERATED ON THE SAME TISSUE SECTION FOR EVALUATION UNDER BRIGHT FIELD MICROSCOPY. THE CISH PROCEDURE IS AUTOMATED USING DAKO AUTOSLAINERINSTRUMENTS. HER2 CISH PHARMDX KIT IS INDICATED AS AN AID IN THE ASSESSMENT OF PATIENTS FOR WHOM HERCEPTIN (TRASTUZUMAB) TREATMENT IS BEING CONSIDERED. RESULTS FROM THE HER2 CISH PHARMDX KIT ARE INTENDED FOR USE AS AN ADJUNCT TO THE CLINICOPATHOLOGIC INFORMATIONCURRENTLY USED FOR ESTIMATING PROGNOSIS IN STAGE II, NODE-POSITIVE BREAST CANCER PATIENTS.
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 |