DAKOCYTOMATION HER2 FISH PHARMDX KIT

System, Test, Her-2/neu, Nucleic Acid Or Serum

FDA Premarket Approval P040005

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 dakocytomation her2 fish pharmdx kit. The device is indicated for: the dakocytomation her2 fish pharmdx kit is a direct fluorescence in situ hybridization (fish) assay designed to quantitatively determine the her2 gene amplification in formalin-fixed, paraffin-embedded breast cancer tissue specimens. Her2 fish pharmdx kit is indicated as an aid in the assessment of patients for whom herceptin (trastuzumab) treatment is being considered. Results form the her2 fish pharmdx kit are intended for use as an adjunct to the clinicopathologic information currently used for estimating prognosis in stage ii, node positive breast cancer patients.

• Device: DAKOCYTOMATION HER2 FISH PHARMDX KIT
• Classification Name: System, Test, Her-2/neu, Nucleic Acid Or Serum
• Generic Name: System, Test, Her-2/neu, Nucleic Acid Or Serum
• Applicant: DAKO DENMARK A/S
• Date Received: 2004-01-29
• Decision Date: 2005-05-03
• Notice Date: 2005-09-23
• PMA: P040005
• Supplement: S
• Product Code: MVD
• Docket Number: 05M-0387
• Advisory Committee: Pathology
• Expedited Review: No
• Combination Product: Yes
• Applicant Address: DAKO DENMARK A/S 42 Produktionsvej 2600 Glostrup DK-26-2600
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Approval Order: Approval Order

Supplemental Filings

Supplement Number	Date	Supplement Type
P040005		Original Filing
S014	2017-03-13	30-day Notice
S013	2016-03-16	30-day Notice
S012	2016-01-08	30-day Notice
S011	2015-08-13	30-day Notice
S010	2013-08-01	30-day Notice
S009	2012-08-24	Normal 180 Day Track
S008	2012-07-11	30-day Notice
S007	2011-12-14	Normal 180 Day Track
S006	2011-12-05	Normal 180 Day Track
S005	2010-04-20	Panel Track
S004	2010-03-10	135 Review Track For 30-day Notice
S003	2008-07-10	Real-time Process
S002	2007-10-29	Real-time Process
S001	2005-08-15	Normal 180 Day Track No User Fee

NIH GUDID Devices

Device ID	PMA	Supp
05700572032465	P040005	001