Identity
- Trade Name
- Ki-67 IHC pharmDx FDA PMA
- Generic Name
- Immunohistochemistry assay, antibody, Ki-67 FDA PMA
Identifiers
- PMA Number
- P210026 FDA PMA
- FDA Product Code
- QQT FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Pathology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
Ki-67 IHC MIB-1 pharmDx is a qualitative immunohistochemical assay designed for the detection of Ki-67 protein in formalin-fixed, paraffin-embedded breast carcinoma tissue. This diagnostic tool is intended to aid in identifying patients with early breast cancer who are at high risk of disease recurrence and are being considered for adjuvant treatment with Verzenio in combination with endocrine therapy.
Frequently asked questions
What is the primary purpose of the Ki-67 IHC MIB-1 pharmDx assay?
The assay is used to detect Ki-67 protein expression in breast carcinoma tissue to help identify patients with early breast cancer who are at a high risk of disease recurrence.
How is Ki-67 expression determined using this assay?
Expression is determined by calculating the Ki-67 pharmDx Score, which represents the overall percentage of viable tumor cells in the invasive cancer component that show Ki-67 nuclear staining.
What score indicates Ki-67 expression?
A specimen is considered to have Ki-67 expression if the Ki-67 pharmDx Score is 20 percent or greater.
Which equipment is required to perform this test?
The assay is intended for use on the Dako Omnis instrument using the EnVision FLEX visualization system.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P210026 | Class III | Active |
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Manufacturer
- Manufacturer
- Agilent Technologies, Inc.
Sources (1)
- FDA PMA P210026 23 fields · synced Sep 18, 2026