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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namechromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer
PMA NumberP100024
Date Received06/22/2010
Decision Date11/30/2011
Product Code
NYQ[ Registered Establishments with NYQ ]
Docket Number 11M-0866
Notice Date 12/09/2011
Advisory Committee Pathology
Expedited Review Granted? No
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Approval for the her2 cish pharmdx kit. This device is indicated tor; her2 cish pharmdx kit is intended for dual-color chromogenic visualization of signals achieved with directly labeled in situ hybridization probes targeting the her2 gene and centromeric region of chromosome 17. The kit is designed to quantitatively determine her2 gene status in formalin-fixed, paraffin-embedded breast cancer tissue specimens. Red and blue chromogenic signals are generated on the same tissue section for evaluation under bright field microscopy. The cish procedure is automated using dako autoslainer instruments. Her2 cish pharmdx kit is indicated as an aid in the assessment of patients for whom herceptin (trastuzumab) treatment is being considered. Results from the her2 cish pharmdx kit are intended for use as an adjunct to the clinicopathologic information currently used for estimating prognosis in stage ii, node-positive breast cancer patients.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007