PATHWAY anti- HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody
FDA premarket approval P990081/S059 · decided 2025-12-15
Approval details
- PMA number
- P990081
- Supplement
- S059
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PATHWAY anti- HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Applicant
- Ventana Medical Systems, Inc.
- Date received
- 2025-08-15
- Decision date
- 2025-12-15
- Days to decision
- 122 days
- Decision code
- APPR
- Product code
- MVC
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- This 180-day supplement is to expand labeling of the PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody assay for use as a companion diagnostic to identify patients with HER2-positive, advanced or metastatic breast cancer who may be eligible for treatment with ENHERTU (fam-trastuzumab deruxtecan-nxki) in combination with PERJETA (pertuzumab) as first-line treatment.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Roche Digital Pathology Dx (K242783) | Ventana Medical Systems, Inc. | 2024-12-17 |
| VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001) (DEN240025) | Ventana Medical Systems, Inc. | 2024-12-05 |
| Roche Digital Pathology Dx (VENTANA DP 200) (K232879) | Ventana Medical Systems, Inc. | 2024-06-14 |
| CINtec Histology (K212176) | Ventana Medical Systems, Inc. | 2021-12-10 |
| 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 |