Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: HER2FISH PHARMDX KIT
• Classification Name: system, test, her-2/neu, nucleic acid or serum
• Generic Name: erbb2 gene amplification kit
• Applicant: DAKO DENMARK A/S
• PMA Number: P040005
• Supplement Number: S003
• Date Received: 07/10/2008
• Decision Date: 10/10/2008
• Product Code: MVD [ Registered Establishments with MVD ]
• Advisory Committee: Immunology
• Supplement Type: real-time process
• Supplement Reason: labeling change - instructions
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for the following changes: 1. Labeling change in the step 1 (pre-treatment) in the instructions for use to include an alternative method to heat the pre-treatment buffer using a microwave oven with boil sensor capability as "water bath" independently of the buffer start volume and temperature 2. Labeling change in the step 2 (pepsin, ready-to-use) in the instructions for use to include an 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 temperature 3. Changes in reagent volume and vial size for vial 1 and vial 2 4. Modification of signal counting guide to include under-digested nuclei 5. Labeling change in the instructions for use to include the dako hybridizer as an alternative to the use of heating block and hybridization oven for denaturation and hybridization steps, respectively.