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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
Generic Namechromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer
3175 staley rd.
grand island, NY 14072
PMA NumberP050040
Date Received11/03/2005
Decision Date07/01/2008
Withdrawal Date 01/07/2015
Product Code
NYQ[ Registered Establishments with NYQ ]
Docket Number 08M-0437
Notice Date 07/31/2008
Advisory Committee Pathology
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for spot-light her2 cish kit. This device is indicated for: the spot-light her2 cish kit is intended to quantitatively determine her2 gene amplification in formalin-fixed, paraffin-embedded (ffpe) breast carcinoma tissue sections using chromogenic in situ hybridization (cish) and brightfield microscopy. This test should be performed in a histopathology laboratory. The spot-light her2 cish kit is indicated as an aid in the assessment of patients for whom herceptin (trastuzumab) treatment is being considered. The assay results are intended for use as an adjunct to the clinicopathological information currently being used as part of the management of breast cancer patients. Interpretation of test results must be made within the context of the patient's clinical history by a qualified pathologist.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003