Ventana ALK (D5F3) CDx Assay

Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

FDA Premarket Approval P140025 S011

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 for minor software and firmware updates for ventana system software on the benchmark ultra instruments.

DeviceVentana ALK (D5F3) CDx Assay
Classification NameImmunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase
Generic NameImmunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase
ApplicantVENTANA MEDICAL SYSTEMS, INC.
Date Received2019-08-22
Decision Date2019-11-19
PMAP140025
SupplementS011
Product CodePKW
Advisory CommitteePathology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product Yes
Applicant Address VENTANA MEDICAL SYSTEMS, INC. 1910 East Innovation Park Dr. tucson, AZ 85755

Supplemental Filings

Supplement NumberDateSupplement Type
P140025Original Filing
S011 2019-08-22 Real-time Process
S010 2018-11-09 30-day Notice
S009 2018-06-18 Real-time Process
S008
S007 2017-07-17 30-day Notice
S006 2017-06-07 Normal 180 Day Track
S005 2016-12-28 Normal 180 Day Track
S004 2016-11-15 Normal 180 Day Track
S003 2016-03-22 Normal 180 Day Track
S002 2015-12-10 135 Review Track For 30-day Notice
S001 2015-08-26 30-day Notice

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