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
- INFORM HER2 DUAL ISH DNA PROBE COCKTAIL
- PMA Number
- P100027
- 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- Approved (Withdrawn)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
- June 14, 2011
- Date Received
- July 12, 2010
- Expedited Review
- N
- Docket Number
- 11M-0472
Advisory Committee Statement
APPROVAL FOR THE INFORM HER2 DUAL ISH DNA PROBE COCKTAIL. THIS DEVICE IS INDICATED FOR:THE INFORM HER2 DUAL ISH DNA PROBE COCKTAIL IS INTENDED FOR USE IN DETERMINING HER2 GENE STATUS BY ENUMERATION OF THE RATIO OF THE HER2 GENE TO CHROMOSOME 17. THE HER2 AND CHROMOSOME 17 PROBES ARE DETECTED USING TWO COLOR CHROMOGENIC IN SITU HYBRIDIZATION (ISH) IN FORMALIN-FIXED. PARAFFIN-EMBEDDED HUMAN BREAST CANCER TISSUE SPECIMENS FOLLOWING STAINING ON VENTANA BENCHMARK XT AUTOMATED SLIDE STAINERS (USING NEXES SOFTWARE), BY LIGHT MICROSCOPY. THE INFORM HER2 DUAL ISH DNA PROBE COCKTAIL IS INDICATED AS AN AID IN THE ASSESSMENT OF PATIENTS FOR WHOM I-HERPCEPTIN (TRASTUZUMAB) TREATMENT IS BEING CONSIDERED.THIS PRODUCT SHOULD BE INTERPRETED BY A QUALIFIED READER IN CONJUNCTION WITH HISTOLOGICAL EXAMINATION, RELEVANT CLINICAL INFORMATION, AND PROPER CONTROLS.THIS REAGENT IS INTENDED FOR IN VITRO DIAGNOSTIC (IVD) USE.
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 |