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.

• Device: NMP22 BLADDERCHEK TEST KIT
• Classification Name: System, Test, Tumor Marker, For Detection Of Bladder Cancer
• Generic Name: System, Test, Tumor Marker, For Detection Of Bladder Cancer
• Applicant: ALERE SCARBOROUGH, INC
• Date Received: 2002-09-16
• Decision Date: 2003-04-25
• PMA: P940035
• Supplement: S003
• Product Code: NAH
• Advisory Committee: Immunology
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf Life/tradename
• Expedited Review: No
• Combination Product: No
• Applicant Address: ALERE SCARBOROUGH, INC 10 Southgate Road scarborough, ME 04074

Supplemental Filings

Supplement Number	Date	Supplement Type
P940035		Original 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 ID	PMA	Supp
10811877010637	P940035	000
10811877010545	P940035	000