System, Test, Her-2/Neu, Nucleic Acid Or Serum
Basic Information
- Device Name
- System, Test, Her-2/Neu, Nucleic Acid Or Serum
- Trade Name
- HER2FISH PHARMDX KIT
- PMA Number
- P040005
- Supplement Number
- S003
- Device Class
- FDA Class 3
- Product Code
- MVD
- Generic Name
- SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
- Medical Specialty
- Unknown
- Advisory Committee
- Pathology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- October 10, 2008
- Date Received
- July 10, 2008
- Supplement Type
- Real-Time Process
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MVD | System, Test, Her-2/Neu, Nucleic Acid Or Serum | FDA class 3 | Unknown |