PATHWAY ANTI-HER-2/NEU (4B5) PRIMARY ANTIBODY
FDA premarket approval P990081/S003 · decided 2007-01-11
Approval details
- PMA number
- P990081
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PATHWAY ANTI-HER-2/NEU (4B5) PRIMARY ANTIBODY
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Applicant
- Ventana Medical Systems, Inc.
- Date received
- 2006-05-04
- Decision date
- 2007-01-11
- Days to decision
- 252 days
- Decision code
- APPR
- Product code
- MVC
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- APPROVAL FOR MODIFICATIONS TO THE PATHWAY C-ERBB-2 PRIMARY ANTIBODY(CLONE CB11) WHICH INCLUDE 1) CHANGE THE PRIMARY ANTIBODY FROM THE MOUSE MONOCLONAL ANTIBODY CB11 TO THE RABBIT MONOCLONAL ANTIBODY 4B5, 2) CHANGE THE DETECTION FORMAT FROM BASIC DAB DETECTION KIT TO THE VENTANA MEDICAL SYSTEMS IVIEW DAB DETECTION KIT, 3) ADD THE OPTIONAL ULTRAVIEW UNIVERSAL DAB DETECTION KIT FOR BIOTIN FREE DETECTION FORMAT, 4) CONSOLIDATE LEVEL 1,3 AND NEGATIVE HER-2 ASSAY CONTROL SLIDES ONTO A SINGLE SLIDE AND
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510(k) clearances by this applicant
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| Virtuoso System for IHC PR (1E2) using iScan HT (K142965) | Ventana Medical Systems, Inc. | 2015-07-16 |
| VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER (K140465) | Ventana Medical Systems, Inc. | 2014-03-20 |