HERCEPTEST

System, Test, Her-2/neu, Ihc

FDA Premarket Approval P980018 S010

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 herceptest kit. The device is indicated for in vitro diagnostic use. Herceptest is a semi-quantitative immunocytochemi-cal assay to determine her2 protein overexpression in breast cancer tissues routinely processed for histological evaluation and formalin-fixed, paraffin-embedded cancer tissue from patients with metastatic gastric or gastroesophageal junction adenocarcinoma. Herceptest is indicated as an aid in the assessment of patients for whom herceptin (trastuzumab) treatment is being considered (see herceptin package insert).

DeviceHERCEPTEST
Classification NameSystem, Test, Her-2/neu, Ihc
Generic NameSystem, Test, Her-2/neu, Ihc
ApplicantDAKO A/S
Date Received2010-04-21
Decision Date2010-10-20
Notice Date2010-11-17
PMAP980018
SupplementS010
Product CodeMVC
Docket Number10M-0557
Advisory CommitteePathology
Supplement TypePanel Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product Yes
Applicant Address DAKO A/S 42 Produktionsvej glostrup DK-26-2600
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P980018Original Filing
S025 2020-06-04 30-day Notice
S024 2018-01-12 30-day Notice
S023 2016-12-27 Real-time Process
S022 2016-06-06 Real-time Process
S021 2016-02-29 Real-time Process
S020 2015-08-13 30-day Notice
S019 2015-04-27 30-day Notice
S018 2013-11-21 Special (immediate Track)
S017 2012-11-01 Normal 180 Day Track
S016 2012-08-24 Normal 180 Day Track
S015 2011-12-05 Normal 180 Day Track
S014 2011-08-15 30-day Notice
S013 2011-04-06 Special (immediate Track)
S012 2011-01-24 30-day Notice
S011 2010-09-09 Normal 180 Day Track
S010 2010-04-21 Panel Track
S009 2010-02-25 Real-time Process
S008 2010-02-12 30-day Notice
S007 2009-12-31 30-day Notice
S006 2008-05-28 Normal 180 Day Track
S005 2005-12-08 Special (immediate Track)
S004 2005-06-20 30-day Notice
S003 2004-11-10 Normal 180 Day Track No User Fee
S002 2003-05-14 30-day Notice
S001 2002-11-15 Real-time Process

NIH GUDID Devices

Device IDPMASupp
05700572032007 P980018 000
05700572031994 P980018 000
05700572031987 P980018 000

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