Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceDAKOCYTOMATION HER2 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
Date Received01/29/2004
Decision Date05/03/2005
Product Code MVD 
Docket Number 05M-0387
Notice Date 09/23/2005
Advisory Committee Pathology
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR THE DAKOCYTOMATION HER2 FISH PHARMDX KIT. THE DEVICE IS INDICATED FOR: THE DAKOCYTOMATION HER2 FISH PHARMDX KIT IS A DIRECT FLUORESCENCE IN SITU HYBRIDIZATION (FISH) ASSAY DESIGNED TO QUANTITATIVELY DETERMINE THE HER2 GENE AMPLIFICATION IN FORMALIN-FIXED, PARAFFIN-EMBEDDED BREAST CANCER TISSUE SPECIMENS. HER2 FISH PHARMDX KIT IS INDICATED AS AN AID IN THE ASSESSMENT OF PATIENTS FOR WHOM HERCEPTIN (TRASTUZUMAB) TREATMENT IS BEING CONSIDERED. RESULTS FORM THE HER2 FISH PHARMDX KIT ARE INTENDED FOR USE AS AN ADJUNCT TO THE CLINICOPATHOLOGIC INFORMATION CURRENTLY USED FOR ESTIMATING PROGNOSIS IN STAGE II, NODE POSITIVE BREAST CANCER PATIENTS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 
-
-