Approval for the intent to manufacture the nmp22 bladderchek test and nmp22 bladderchek control kit under alere scarborough, inc. Brand name. The devices, as modified, will be marketed under the following trade name: alere nmp22 bladderchek test, with the following intended use: the alere nmp22 bladderchek test is an in vitro immunoassay intended for the qualitative detection of the nuclear mitotic apparatus protein (numa), which is an abundant component of the nuclear matrix proteins, 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. Alere nmp22 bladderchek control kit, with the following intended use: alere nmp22 bladderchek control kit is designed to provide the users of the alere nmp22 bladderchek test with additional, optional, quality controls for operating the test.
| Device | ALERE NMP22 BLADDERCHECK TEST & CONTROL 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 | 2010-11-22 |
| Decision Date | 2012-03-21 |
| PMA | P940035 |
| Supplement | S008 |
| Product Code | NAH |
| Advisory Committee | Immunology |
| Supplement Type | Normal 180 Day Track No User Fee |
| 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