- Device
- ALERE NMP22 BLADDERCHECK TEST & CONTROL KIT
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- PMA number
- P940035
- Supplement
- S008
- Product code
- NAH
- Generic name
- System, test, tumor marker, for detection of bladder cancer
- Decision date
- 2012-03-21
- Decision code
- APPR
- Date received
- 2010-11-22
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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.