HER2FISH PHARMDX KIT

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

FDA Premarket Approval P040005 S003

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 the following changes:1. Labeling change in the step 1 (pre-treatment) in the instructions for use to include analternative method to heat the pre-treatment buffer using a microwave oven with boilsensor capability as "water bath" independently of the buffer start volume andtemperature2. Labeling change in the step 2 (pepsin, ready-to-use) in the instructions for use to includean alternative method of incubation with pepsin using a heating block, e. G. A hybridizer,and incubation at 37°c as an alternative to incubation at room temperature3. Changes in reagent volume and vial size for vial 1 and vial 24. Modification of signal counting guide to include under-digested nuclei5. Labeling change in the instructions for use to include the dako hybridizer as analternative to the use of heating block and hybridization oven for denaturation andhybridization steps, respectively.

• Device: HER2FISH 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: 2008-07-10
• Decision Date: 2008-10-10
• PMA: P040005
• Supplement: S003
• Product Code: MVD
• Advisory Committee: Pathology
• Supplement Type: Real-time Process
• Supplement Reason: Labeling Change - Indications/instructions/shelf Life/tradename
• Expedited Review: No
• Combination Product: No
• Applicant Address: DAKO DENMARK A/S 42 Produktionsvej 2600 Glostrup DK-26-2600

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