NMP22 BLADDERCHEK TEST KIT

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Premarket Approval P940035 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 new test format to be manufactured at matritech, inc. , newton, massachusetts and at a new facility, unotech diagnostics, inc. , san leandro, california. The device, as modified, will be marketed under the trade name nmp22 bladderchek kit and is indicated for the following: the matritech nmp22 bladderchek test is an in vitro immunoassay intended for the qualitative detection of nmp22 nuclear matrix protein in urine of persons with risk factors or symptoms of bladder cancer or with a history of bladder cancer. This test is indicated for professional use and prescription home use as an aid in diagnosing and monitoring bladder cancer patients, in conjunction with standard diagnostic procedures.

DeviceNMP22 BLADDERCHEK TEST KIT
Classification NameSystem, Test, Tumor Marker, For Detection Of Bladder Cancer
Generic NameSystem, Test, Tumor Marker, For Detection Of Bladder Cancer
ApplicantALERE SCARBOROUGH, INC
Date Received2002-09-16
Decision Date2003-04-25
PMAP940035
SupplementS003
Product CodeNAH
Advisory CommitteeImmunology
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address ALERE SCARBOROUGH, INC 10 Southgate Road scarborough, ME 04074

Supplemental Filings

Supplement NumberDateSupplement Type
P940035Original Filing
S017 2022-02-08 Normal 180 Day Track No User Fee
S016 2021-05-27 30-day Notice
S015 2018-04-18 30-day Notice
S014 2017-01-30 30-day Notice
S013 2016-08-16 30-day Notice
S012 2016-04-06 30-day Notice
S011 2015-07-01 30-day Notice
S010 2013-07-10 Special (immediate Track)
S009 2013-03-18 30-day Notice
S008 2010-11-22 Normal 180 Day Track No User Fee
S007 2011-07-27 Normal 180 Day Track No User Fee
S006 2011-05-11 Normal 180 Day Track No User Fee
S005 2008-05-16 Normal 180 Day Track No User Fee
S004 2008-03-27 Normal 180 Day Track No User Fee
S003 2002-09-16 Normal 180 Day Track
S002 1999-07-23 Panel Track
S001 1996-12-16 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
10811877010637 P940035 000
10811877010545 P940035 000

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