PMA P980018S010
- Device
- HERCEPTEST
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- PMA number
- P980018
- Supplement
- S010
- Product code
- MVC
- Decision date
- 2010-10-20
- Classification
- System, Test, Her-2/neu, Ihc
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Approval order 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) TREATMENT IS BEING CONSIDERED (SEE HERCEPTIN PACKAGE INSERT).
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P980018S010B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- HERCEPTEST
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- PMA number
- P980018
- Supplement
- S010
- Product code
- MVC
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Decision date
- 2010-10-20
- Decision code
- APPR
- Date received
- 2010-04-21
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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) TREATMENT IS BEING CONSIDERED (SEE HERCEPTIN PACKAGE INSERT).