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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.
 
DeviceHER2 FISH PHARMDX KIT
Generic NameSYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
ApplicantAgilent Technologies Singapore (International) Pte Ltd.
No. 1 Yishun Avenue 7
Singapore 76892
PMA NumberP040005
Supplement NumberS005
Date Received04/20/2010
Decision Date10/20/2010
Product Code MVD 
Docket Number 10M-0558
Notice Date 11/18/2010
Advisory Committee Pathology
Clinical TrialsNCT01041404
Supplement TypePanel Track
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR THE HER2 FISH PHARMDX KIT. THE DEVICE IS INDICATED FOR IN VITRO DIAGNOSTIC USE. THE HER2 FISH PHARMDX KIT IS A DIRECT FLUORESCENCE IN SITU HYBRIDIZATION (FISH) ASSAY DESIGNED TO QUANTITATIVELY DETERMINE HER2 GENE AMPLIFICATION IN FORMALIN-FIXED, PARAFFIN-EMBEDDED (FFPE) BREAST CANCER TISSUE SPECIMENS AND FFPE SPECIMENS FROM PATIENTS WITH METASTATIC GASTRIC OR GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA. HER2 FISH PHARMDX KIT 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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