VYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALK

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Premarket Approval P110012

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the vysis alk break apart fish probe kit; vysis paraffin pretreatment iv & post hybridization wash buffer kit; probechek alk negative control slides; and probechek alk positive control slides. This device is indicated for: 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) non-small cell lung cancer (nsclc) tissue specimens to aid in identifying those patients eligible for treatment with xalkori crizotinib). The test is for prescription use only. The vysis paraffin pretreatment iv & post hybridization wash buffer kit is used to prepare paraffin-embedded lung cancer tissue sections fixed on positively charged slides for use in fluorescence in situ hybridization (fish) with vysis dna fish probes. The probechek alk negative control slides are intended for use as an assay control for appropriate hybridization conditions during routine use of the vysis alk break apart fish probe kit (list no. 06n38-020). The probechek alk negative control slides should be assayed in conjunction with the user's specimen slides according the package insert for the vysis alk break apart fish probe kit (list no. 06n38-020). The probechek alk positive control slides are intended for use as an assay control for appropriate hybridization conditions during routine use of the vysis alk break apart fish probe kit (list no. 06n38-020). The probechek alk positive control slides should be assayed in conjunction with the user's specimen slides according the package insert for the vysis alk break apart fish probe kit (list no. 06n38-020).

DeviceVYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALK
Classification NameFluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement
Generic NameFluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement
ApplicantABBOTT MOLECULAR, INC.
Date Received2011-04-01
Decision Date2011-08-26
Notice Date2011-09-06
PMAP110012
SupplementS
Product CodeOWE
Docket Number11M-0630
Advisory CommitteePathology
Expedited ReviewYes
Combination Product Yes
Applicant Address ABBOTT MOLECULAR, INC. 1300 East Touhy Avenue des Plaines, IL 60018
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Approval Order: Approval Order

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.