PD-L1 IHC 28-8 pharmDx
FDA premarket approval P150025/S013 · decided 2020-05-15
Approval details
- PMA number
- P150025
- Supplement
- S013
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PD-L1 IHC 28-8 pharmDx
- Generic name
- Immunohistochemistry assay, antibody, programmed death-ligand 1
- Applicant
- Agilent Technologies, Inc.
- Date received
- 2019-12-16
- Decision date
- 2020-05-15
- Days to decision
- 151 days
- Decision code
- APPR
- Product code
- PLS
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- Approval application (PMA) supplement submitted to expand the indication for the PD-L1 IHC 28-8 pharmDx to include detection of PD-L1 protein in NSCLC patients for treatment with OPDIVO® (nivolumab) in combination with YERVOY® (ipilimumab). The device, as modified, will be marketed under the trade name PD-L1 IHC 28-8 pharmDx and is indicated for in vitro diagnostic use.PD-L1 IHC 28-8 pharmDx is a qualitative immunohistochemical assay using Monoclonal Rabbit Anti-PD-L1, Clone 28-8 intended for us
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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 |