FDA.reportPublic FDA data

PMA P210026S001

Device
Ki-67 IHC MIB-1 pharmDx (Dako Omnis)
Applicant
Agilent Technologies, Inc.
PMA number
P210026
Supplement
S001
Product code
QQT
Decision date
2024-09-04
Classification
Pathology
Generic name
Immunohistochemistry assay, antibody, Ki-67
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.

Current openFDA PMA Record#

Device
Ki-67 IHC MIB-1 pharmDx (Dako Omnis)
Applicant
Agilent Technologies, Inc.
PMA number
P210026
Supplement
S001
Product code
QQT
Generic name
Immunohistochemistry assay, antibody, Ki-67
Decision date
2024-09-04
Decision code
APPR
Date received
2024-08-09
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
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.