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. |
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Device | PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody |
Generic Name | SYSTEM, TEST, HER-2/NEU, IHC |
Applicant | VENTANA MEDICAL SYSTEMS, INC. 1910 E. Innovation Park Dr. Tucson, AZ 85755 |
PMA Number | P990081 |
Supplement Number | S054 |
Date Received | 04/26/2024 |
Decision Date | 11/20/2024 |
Product Code |
MVC |
Advisory Committee |
Pathology |
Clinical Trials | NCT04466891
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Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement 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: Indication for use Status TherapyBreast carcinoma IHC 3+ or IHC 2+/ISH amplified Herceptin®Breast carcinoma IHC 3+ or IHC 2+/ISH amplified KADCYLA®Breast carcinoma 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 product is intended for in vitro diagnostic (IVD) use. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
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