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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceHERCEPTEST
Generic NameSYSTEM, TEST, HER-2/NEU, IHC
ApplicantAgilent Technologies Singapore (International) Pte Ltd.
No. 1 Yishun Avenue 7
Singapore 76892
PMA NumberP980018
Supplement NumberS010
Date Received04/21/2010
Decision Date10/20/2010
Product Code MVC 
Docket Number 10M-0557
Notice Date 11/17/2010
Advisory Committee Pathology
Clinical TrialsNCT01041404
Supplement TypePanel Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
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).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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