- Device
- ALERE NMP22 URINE COLLECTION KIT
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- PMA number
- P940035
- Supplement
- S007
- Product code
- NAH
- Generic name
- System, test, tumor marker, for detection of bladder cancer
- Decision date
- 2012-01-20
- Decision code
- APPR
- Date received
- 2011-07-27
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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.