Approval of ki-67 ihc mib-1 pharmdx (dako omnis)for in vitro diagnostic use. Ki-67 ihc mib-1 pharmdx (dako omnis) is a qualitative immunohistochemical (ihc) assay using monoclonal mouse anti-ki-67, clone mib-1, intended for use in the detection of ki-67 protein in formalin-fixed, paraffin-embedded (ffpe) breast carcinoma tissue using the envision flex visualization system on dako omnis. Ki-67 protein expression in breast carcinoma is determined by using the ki-67 pharmdx score, which is the overall percentage of viable tumor cells in the invasive cancer component showing ki-67 nuclear staining. The specimen should be considered to have ki-67 expression if ki-67 pharmdx score is? 20. Ki-67 ihc mib-1 pharmdx (dako omnis) is indicated as an aid in identifying patients with early breast cancer at high risk of disease recurrence for whom adjuvant treatment with verzenio® (abemaciclib) in combination with endocrine therapy is being considered.
| Device | Ki-67 IHC pharmDx |
| Generic Name | Immunohistochemistry Assay, Antibody, Ki-67 |
| Applicant | Agilent Technologies, Inc. |
| Date Received | 2021-06-30 |
| Decision Date | 2021-10-12 |
| PMA | P210026 |
| Supplement | S |
| Product Code | QQT |
| Advisory Committee | Pathology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Agilent Technologies, Inc. 5301 Stevens Creek Boulevard santa Clara, CA 95051 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P210026 | | Original Filing |
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NIH GUDID Devices