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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 BLADDERCHECK TEST & CONTROL KIT
Generic NameSystem, test, tumor marker, for detection of bladder cancer
ApplicantAbbott Diagnostics Scarborough, Inc.
10 Southgate Road
Scarborough, ME 04074
PMA NumberP940035
Supplement NumberS008
Date Received11/22/2010
Decision Date03/21/2012
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 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.
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