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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 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.
Classification Namesystem, test, her-2/neu, nucleic acid or serum
Generic Namesystem, test, her-2/neu, nucleic acid or serum
42 produktionsvej
2600 glostrup DK-26-2600
PMA NumberP040005
Supplement NumberS005
Date Received04/20/2010
Decision Date10/20/2010
Product Code
MVD[ Registered Establishments with MVD ]
Docket Number 10M-0558
Notice Date 11/18/2010
Advisory Committee Pathology
Clinical Trials NCT01041404
Supplement Typepanel track
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the her2 fish pharmdx kit. The device is indicated for in vitro diagnostic use. The her2 fish pharmdx kit is a direct fluorescence in situ hybridization (fish) assay designed to quantitatively determine her2 gene amplification in formalin-fixed, paraffin-embedded (ffpe) breast cancer tissue specimens and ffpe specimens from patients with metastatic gastric or gastroesophageal junction adenocarcinoma. Her2 fish pharmdx kit is indicated as an aid in the assessment of patients for whom herceptin (trastuzumab) treatment is being considered (see herceptin package insert).
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling