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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.
 
DeviceHER2FISH PHARMDX KIT
Generic NameSystem, Test, Her-2/Neu, Nucleic Acid Or Serum
Regulation Number864.1890
ApplicantAgilent Technologies Singapore (International) Pte , Ltd.
# 1 Yishun Ave. 7
Singapore 768923
PMA NumberP040005
Supplement NumberS003
Date Received07/10/2008
Decision Date10/10/2008
Product Code MVD 
Advisory Committee Pathology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE FOLLOWING CHANGES:1. LABELING CHANGE IN THE STEP 1 (PRE-TREATMENT) IN THE INSTRUCTIONS FOR USE TO INCLUDE ANALTERNATIVE METHOD TO HEAT THE PRE-TREATMENT BUFFER USING A MICROWAVE OVEN WITH BOILSENSOR CAPABILITY AS "WATER BATH" INDEPENDENTLY OF THE BUFFER START VOLUME ANDTEMPERATURE2. LABELING CHANGE IN THE STEP 2 (PEPSIN, READY-TO-USE) IN THE INSTRUCTIONS FOR USE TO INCLUDEAN ALTERNATIVE METHOD OF INCUBATION WITH PEPSIN USING A HEATING BLOCK, E.G. A HYBRIDIZER,AND INCUBATION AT 37°C AS AN ALTERNATIVE TO INCUBATION AT ROOM TEMPERATURE3. CHANGES IN REAGENT VOLUME AND VIAL SIZE FOR VIAL 1 AND VIAL 24. MODIFICATION OF SIGNAL COUNTING GUIDE TO INCLUDE UNDER-DIGESTED NUCLEI5. LABELING CHANGE IN THE INSTRUCTIONS FOR USE TO INCLUDE THE DAKO HYBRIDIZER AS ANALTERNATIVE TO THE USE OF HEATING BLOCK AND HYBRIDIZATION OVEN FOR DENATURATION ANDHYBRIDIZATION STEPS, RESPECTIVELY.
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