INFORM HER2 DUAL ISH DNA PROBE COCKTAIL
FDA premarket approval P100027/S002 · decided 2012-02-15
Approval details
- PMA number
- P100027
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INFORM HER2 DUAL ISH DNA PROBE COCKTAIL
- Generic name
- Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
- Applicant
- Ventana Medical Systems, Inc.
- Date received
- 2011-09-19
- Decision date
- 2012-02-15
- Days to decision
- 149 days
- Decision code
- APPR
- Product code
- NYQ
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Tucson, AZ
- 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
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