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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: 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.
 
DeviceALERE NMP22 URINE COLLECTION KIT
Generic NameSystem, test, tumor marker, for detection of bladder cancer
ApplicantAbbott Diagnostics Scarborough, Inc.
10 Southgate Road
Scarborough, ME 04074
PMA NumberP940035
Supplement NumberS007
Date Received07/27/2011
Decision Date01/20/2012
Product Code NAH 
Advisory Committee Immunology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
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.
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