Approval for the nmp22 test kit and nmp22 urine collection kit under alere scarborough, incs brand name. The devices, as modified, will be marketed under: trade name alere nmp22 test with the following intended use: alere nmp22 test is an enzyme immunoassay (eia) for the in vitro quantitative determination of the nuclear mitotic apparatus protein (numa) in stabilized voided urine. The alere nmp22 test kit is indicated 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. 5 u/ml) in conjunction with, and not in lieu of, current standard diagnostic procedures, and 2) in management of patients of transitional cell carcinoma of the bladder, after surgical treatment to identify those patients with occult or rapidly recurring tcc (cut-off > 10 u/ml). Trade name alere nmp22 urine collection kit, with the following intended use: the alere nmp22 urine collection kit is intended for the collection, stabilization, and transport of human urine which will be tested using the alere nmp22 test kit.
Device | ALERE NMP22 URINE COLLECTION 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 | 2011-07-27 |
Decision Date | 2012-01-20 |
PMA | P940035 |
Supplement | S007 |
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