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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.
 
DevicePD-L1 IHC 22C3 pharmDx
Generic NameImmunohistochemistry assay, antibody, programmed death-ligand 1
ApplicantAgilent Technologies, Inc.
5301 Stevens Creek Blvd.
Santa Clara, CA 95051
PMA NumberP150013
Supplement NumberS031
Date Received07/28/2025
Decision Date03/19/2026
Product Code PLS 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to migrate the PD-L1 IHC 22C3 pharmDx assay using the Autostainer Link 48 for esophageal squamous cell carcinoma (ESCC) with CPS>=10, triple-negative breast cancer (TNBC) with CPS>=10, cervical cancer with CPS>=1, and gastric or gastroesophageal junction (GEJ) adenocarcinoma with CPS>=1 indication to the Dako Omnis automated staining system.
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