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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
Generic Namefluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
1300 east touhy avenue
des plaines, IL 60018
PMA NumberP110012
Supplement NumberS010
Date Received06/01/2016
Decision Date07/13/2016
Product Code OWE 
Advisory Committee Pathology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Removal of testing at the cell pellet stage for 2 components of the PathVysion HER-2 DNA Probe Kit: (1) ProbeChek HER-2/neu Cut-Off Control Slides (List No. 02J04-030), (2) ProbeChek HER-2/neu Normal Control Slides (List No. 02J05-030). The second change involves adding the RM2255 Rotary Microtome to the manufacturing procedures of the ProbeChek HER-2/neu Cut-Off Control Slides, the ProbeChek Her-2/neu Normal Control Slides, and 2 components of the Vysis ALK Break Apart FISH Probe Kit: (1) ProbeChek ALK Negative Control Slides (06N38-005), (2) ProbeChek ALK Postitive Control Slides (06N38-010).