Vysis ALK Break Apart Fish Probe Kit

FDA Premarket Approval P110012 S020

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.

Pre-market Approval Supplement Details

Approval of the expansion of the indications for use for the vysis alk break apart fish probe kit to include an indication for alunbrig® (brigatinib). The device, as modified, will be marketed under the trade name vysis alk break apart fish probe kit and is indicated for:intended use the vysis alk break apart fish probe kit is a qualitative test to detect rearrangements involving the alk gene via fluorescence in situ hybridization (fish) in formalin-fixed paraffin-embedded (ffpe) tissue specimens from non-small cell lung cancer (nsclc) patients. Indication for usethe vysis alk break apart fish probe kit is indicated as an aid in identifying patients eligible for treatment with xalkori® (crizotinib) and alunbrig® (brigatinib) in accordance with the approved therapeutic product labeling.

DeviceVysis ALK Break Apart Fish Probe Kit
Generic NameFluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement
ApplicantABBOTT MOLECULAR, INC.
Date Received2019-12-23
Decision Date2020-05-22
PMAP110012
SupplementS020
Product CodeOWE 
Advisory CommitteePathology
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product Yes
Applicant Address ABBOTT MOLECULAR, INC. 1300 East Touhy Avenue des Plaines, IL 60018

Supplemental Filings

Supplement NumberDateSupplement Type
P110012Original Filing
S021 2020-11-16 30-day Notice
S020 2019-12-23 Normal 180 Day Track
S019 2019-07-31 30-day Notice
S018 2019-04-10 30-day Notice
S017 2018-08-10 30-day Notice
S016 2018-06-15 30-day Notice
S015 2018-02-16 30-day Notice
S014 2017-11-08 30-day Notice
S013 2016-11-22 Real-time Process
S012 2016-09-12 30-day Notice
S011 2016-09-02 30-day Notice
S010 2016-06-01 30-day Notice
S009 2014-10-01 Normal 180 Day Track
S008 2014-07-24 30-day Notice
S007 2014-08-14 Real-time Process
S006 2014-06-16 30-day Notice
S005 2013-11-05 30-day Notice
S004 2013-08-29 Normal 180 Day Track No User Fee
S003 2013-03-20 30-day Notice
S002 2012-11-15 30-day Notice
S001 2011-12-19 135 Review Track For 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00884999025745 P110012 001
00884999000735 P110012 001
00884999042773 P110012 009
00884999042728 P110012 009
00884999038189 P110012 009

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