MATRITECH NMP22 TEST KIT

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

FDA Premarket Approval P940035 S002

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

The device is used as an aid 1)in the diagnosis of persons with symptoms or risk factors for transitional cell cancer (tcc) of the bladder (cut-off >= 7. 5u/ml) in conjunction with and not in lieu of current standard diagnostic procedures and 2) in the management of patients with transitional cell carcinoma of the bladder, after surgical treatment to identify those patients with occult or rapidly recurring tcc (cut-off >10u/ml).

• Device: MATRITECH NMP22 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: 1999-07-23
• Decision Date: 2000-01-18
• Notice Date: 2000-09-21
• PMA: P940035
• Supplement: S002
• Product Code: NAH
• Docket Number: 00M-1522
• Advisory Committee: Immunology
• Supplement Type: Panel 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
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Approval Order: Approval Order

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