Ki-67 IHC MIB-1 pharmDx (Dako Omnis)
FDA premarket approval P210026/S001 · decided 2024-09-04
Approval details
- PMA number
- P210026
- Supplement
- S001
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Ki-67 IHC MIB-1 pharmDx (Dako Omnis)
- Generic name
- Immunohistochemistry assay, antibody, Ki-67
- Applicant
- Agilent Technologies, Inc.
- Date received
- 2024-08-09
- Decision date
- 2024-09-04
- Days to decision
- 26 days
- Decision code
- APPR
- Product code
- QQT
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Santa Clara, CA
- 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
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| GenetiSure Dx Postnatal Assay (K163367) | Agilent Technologies, Inc. | 2017-08-11 |
| MODIFICATION TO DEVICE LINK SYSTEM, MODEL M2376A (K012094) | Agilent Technologies, Inc. | 2001-07-20 |
| AGILENT M2636B TELEMON B MONITOR (TELEMON B) (K011824) | Agilent Technologies, Inc. | 2001-07-02 |
| HEARTSTREAM XL DEFIBIBRILLATOR/MONITOR, MODEL M4735A, HEARTSTREAM XLT DEFIBRILLATOR/MONITOR.MODEL M2500B (K010634) | Agilent Technologies, Inc. | 2001-06-11 |
| M2376A DEVICELINK SYSTEM, MODEL M2376A (K011578) | Agilent Technologies, Inc. | 2001-06-08 |
| HEARTSTREAM ATTENUATED DEFIBRILLATION PADS, MODEL M3870A (K003819) | Agilent Technologies, Inc. | 2001-05-02 |
| AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154 (K011093) | Agilent Technologies, Inc. | 2001-05-01 |
| M2376A DEVICELINK SYSTEM (K010453) | Agilent Technologies, Inc. | 2001-03-02 |