Alere NMP22 BladderChek Test

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

FDA Premarket Approval P940035 S013

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

Additional vendor for the goat anti-mouse lgg antibody used in the manufacture of the alere nmp22® bladderchek® test procedural control line.

• Device: Alere NMP22 BladderChek Test
• 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: 2016-08-16
• Decision Date: 2016-09-08
• PMA: P940035
• Supplement: S013
• Product Code: NAH
• Advisory Committee: Immunology
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• 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