Premarket Approval (PMA)

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.

• Device: Ki-67 IHC MIB-1 pharmDx (Dako Omnis)
• Generic Name: Immunohistochemistry assay, antibody, Ki-67
• Applicant: Agilent Technologies, Inc.; 5301 Stevens Creek Blvd.; Santa Clara, CA 95051
• PMA Number: P210026
• Supplement Number: S001
• Date Received: 08/09/2024
• Decision Date: 09/04/2024
• Product Code: QQT
• Advisory Committee: Pathology
• Supplement Type: Special (Immediate Track)
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your premarket approval application (PMA) supplement which requested for removal of the device from the market since the drug Abemaciclib has received expanded approval and no longer requires Ki-67 IHC MIB-1 pharmDx (Dako Omnis) testing to determine eligibility of early breast cancer patients at high risk of disease recurrence for consideration of treatment with Abemaciclib in combination with endocrine therapy. Your submission meets the criteria in 21 CFR 814.39(d)(2) for a "Special PMA Supplement - Changes Being Effected." Based upon the information submitted, the PMA supplement is approved.