HERCEPTEST
FDA premarket approval P980018/S010 · decided 2010-10-20
Approval details
- PMA number
- P980018
- Supplement
- S010
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HERCEPTEST
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- Date received
- 2010-04-21
- Decision date
- 2010-10-20
- Days to decision
- 182 days
- Decision code
- APPR
- Product code
- MVC
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Singapore
- Statement
- APPROVAL FOR THE HERCEPTEST KIT. THE DEVICE IS INDICATED FOR IN VITRO DIAGNOSTIC USE. HERCEPTEST IS A SEMI-QUANTITATIVE IMMUNOCYTOCHEMI-CAL 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 INDICATED AS AN AID IN THE ASSESSMENT OF PATIENTS FOR WHOM HERCEPTIN (TRASTUZUMAB) TREATMEN
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