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).

DeviceMATRITECH NMP22 TEST KIT
Classification NameSystem, Test, Tumor Marker, For Detection Of Bladder Cancer
Generic NameSystem, Test, Tumor Marker, For Detection Of Bladder Cancer
ApplicantALERE SCARBOROUGH, INC
Date Received1999-07-23
Decision Date2000-01-18
Notice Date2000-09-21
PMAP940035
SupplementS002
Product CodeNAH
Docket Number00M-1522
Advisory CommitteeImmunology
Supplement TypePanel Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
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 NumberDateSupplement Type
P940035Original 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 IDPMASupp
10811877010637 P940035 000
10811877010545 P940035 000

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