HERCEP TEST
FDA premarket approval P980018/S015 · decided 2012-06-08
Approval details
- PMA number
- P980018
- Supplement
- S015
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HERCEP TEST
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- Date received
- 2011-12-05
- Decision date
- 2012-06-08
- Days to decision
- 186 days
- Decision code
- APPR
- Product code
- MVC
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Singapore
- Statement
- APPROVAL FOR ADDITION OF PERTUZUMAB IN THE LABELING OF HERCEPTEST. THEDEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HERCEPTEST AND ITS INDICATION FOR USE IS: HERCEPTEST IS A SEMI-QUANTITATIVE IMMUNOHISTO-CHEMICAL ASSAY TO DETERMINE HER2 PROTEIN OVEREXPRESSION IN BREAST CANCER TISSUES ROUTINELY PROCESSED FOR HISTOLOGICAL EVALUATION AND FORMALIN-FIXED, PARAFFIN-EMBEDDED CANCER TISSUE FROM PATIENTS WITH METASTATIC GASTRIC OR GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA. HERCEPTEST IS INDIC
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