Immunohistochemistry Assay, Antibody, Ki-67
Basic Information
- Device Name
- Immunohistochemistry Assay, Antibody, Ki-67
- Trade Name
- Ki-67 IHC MIB-1 pharmDx (Dako Omnis)
- PMA Number
- P210026
- Supplement Number
- S001
- Device Class
- FDA Class 3
- Product Code
- QQT
- Generic Name
- Immunohistochemistry assay, antibody, Ki-67
- Medical Specialty
- Unknown
- Advisory Committee
- Pathology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- September 4, 2024
- Date Received
- August 9, 2024
- Supplement Type
- Special (Immediate Track)
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QQT | Immunohistochemistry Assay, Antibody, Ki-67 | FDA class 3 | Unknown |