PD-L1 IHC 22C3 pharmDx
FDA premarket approval P150013/S027 · decided 2023-11-07
Approval details
- PMA number
- P150013
- Supplement
- S027
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PD-L1 IHC 22C3 pharmDx
- Generic name
- Immunohistochemistry assay, antibody, programmed death-ligand 1
- Applicant
- Agilent Technologies, Inc.
- Date received
- 2023-09-20
- Decision date
- 2023-11-07
- Days to decision
- 48 days
- Decision code
- APPR
- Product code
- PLS
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- Approval for an expansion of the current PD-L1 IHC 22C3 pharmDX indication to include a companion diagnostic (CDx) indication to use as an aid in identifying gastric or gastroesophageal junction (GEJ) adenocarcinoma patients for treatment with KEYTRUDA® (pembrolizumab).
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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 |