- Device
- HER2FISH PHARMDX KIT
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- PMA number
- P040005
- Supplement
- S003
- Product code
- MVD
- Generic name
- SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
- Decision date
- 2008-10-10
- Decision code
- APPR
- Date received
- 2008-07-10
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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.