PATHWAY HER-2/NEU (CLONE CD11) PRIMARY ANTIBODY
FDA premarket approval P990081/S002 · decided 2005-10-21
Approval details
- PMA number
- P990081
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PATHWAY HER-2/NEU (CLONE CD11) PRIMARY ANTIBODY
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Applicant
- Ventana Medical Systems, Inc.
- Date received
- 2005-09-06
- Decision date
- 2005-10-21
- Days to decision
- 45 days
- Decision code
- APPR
- Product code
- MVC
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- APPROVAL OF LABELING CHANGES FOR THE PATHWAY HER-2/NEU (CLONE CD11) IN THE "INTENDED USE" SECTION, ADDITION OF AN "OPTIONAL EQUIPMENT NOT PROVIDED" SECTION AND CHANGES TO THE "PRINCIPLES AND PROCEDURES" SECTION TO REFLECT THE ADDITION OF TRIPATH IMAGING VIAS INSTRUMENT TO BE USED IN CONJUNCTION WITH THE VENTANA PATHWAY HER 2 ASSAY AS AN OPTIONAL ACCESSORY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE SAME TRADE NAME PATYHWAY HER-2/NEU (CLONE CD11) AND IS INDICATED: VENTANA MEDICAL SYSTEMS
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510(k) clearances by this applicant
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|---|---|---|
| Roche Digital Pathology Dx (K242783) | Ventana Medical Systems, Inc. | 2024-12-17 |
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| VENTANA CD30 (Ber-H2) RxDx Assay (K172471) | Ventana Medical Systems, Inc. | 2018-05-08 |
| CINtec Histology (50 tests), CINtec Histology (250 tests) (DEN160019) | Ventana Medical Systems, Inc. | 2017-03-04 |
| 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 |