PMA P100027S002
- Device
- INFORM HER2 DUAL ISH DNA PROBE COCKTAIL
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P100027
- Supplement
- S002
- Product code
- NYQ
- Decision date
- 2012-02-15
- Classification
- Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/neu Gene, Breast Cancer
- Generic name
- Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
- Approval order statement
- APPROVAL FOR MIGRATION OF THE INFORM HER2 DUAL ISH DNA PROBE COCKTAIL ASSAY TO THE BENCHMARK ULTRA AUTO-STAINER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INFORM HER2 DUAL ISH DNA PROBE COCKTAIL ASSAY AND IS INDICATED FOR USE INDETERMINING 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), OR ON VENTANA BENCHMARK ULTRA AUTOMATED SLIDE STAINER (USING VSS SOFTWARE), BY LIGHTMICROSCOPY. THE INFORM HER2 DUAL ISH DNA PROBE COCKTAIL IS INDICATED AS AN AID IN THE ASSESSMENT OF PATIENTS FOR WHOM HERCEPTIN (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.
Current openFDA PMA Record#
- Device
- INFORM HER2 DUAL ISH DNA PROBE COCKTAIL
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P100027
- Supplement
- S002
- Product code
- NYQ
- Generic name
- Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
- Decision date
- 2012-02-15
- Decision code
- APPR
- Date received
- 2011-09-19
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MIGRATION OF THE INFORM HER2 DUAL ISH DNA PROBE COCKTAIL ASSAY TO THE BENCHMARK ULTRA AUTO-STAINER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INFORM HER2 DUAL ISH DNA PROBE COCKTAIL ASSAY AND IS INDICATED FOR USE INDETERMINING 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), OR ON VENTANA BENCHMARK ULTRA AUTOMATED SLIDE STAINER (USING VSS SOFTWARE), BY LIGHTMICROSCOPY. THE INFORM HER2 DUAL ISH DNA PROBE COCKTAIL IS INDICATED AS AN AID IN THE ASSESSMENT OF PATIENTS FOR WHOM HERCEPTIN (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.