- Device
- PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P990081
- Supplement
- S055
- Product code
- MVC
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Decision date
- 2025-01-27
- Decision code
- APPR
- Date received
- 2024-08-23
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval Order:Approval for the PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody for expanding the indications to include testing for HER2-ultralow (IHC 0 with membrane staining) breast cancer patients who are eligible for treatment with ENHERTU.Intended Use:PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (PATHWAY anti-HER2 (4B5) antibody) is a rabbit monoclonal antibody intended for laboratory use for the semi-quantitative detection of HER2 antigen by immunohistochemistry (IHC) in sections of formalin-fixed, paraffin-embedded breast carcinoma and biliary tract cancer (gallbladder adenocarcinoma, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma) tissue using the ultraView Universal DAB Detection Kit on a BenchMark ULTRA instrument.The IHC device is indicated for identifying patients who are eligible for treatment with the following therapies in accordance with the approved therapeutic labeling:Indications for Use HER2 Score TherapyBreast carcinoma IHC 3+ or IHC 2+/ISH amplified Herceptin®Breast carcinoma IHC 3+ or IHC 2+/ISH amplified KADCYLA®Breast carcinoma IHC 0 with membrane staining, IHC 1+ or IHC 2+/ISH non-amplified ENHERTU®Biliary tract cancer IHC 3+ ZIIHERA®Test results should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls.This antibody is intended for in vitro diagnostic (IVD) use.