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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody
Generic NameSYSTEM, TEST, HER-2/NEU, IHC
ApplicantVENTANA MEDICAL SYSTEMS, INC.
1910 E. Innovation Park Dr.
Tucson, AZ 85755
PMA NumberP990081
Supplement NumberS055
Date Received08/23/2024
Decision Date01/27/2025
Product Code MVC 
Docket Number 25M-0340
Notice Date 01/31/2025
Advisory Committee Pathology
Clinical TrialsNCT04494425
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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