Premarket Approval (PMA)

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.

• Device: Alere NMP22 BladderChek Test
• Generic Name: System, test, tumor marker, for detection of bladder cancer
• Applicant: Abbott Diagnostics Scarborough, Inc.; 10 Southgate Rd.; Scarborough, ME 04074
• PMA Number: P940035
• Supplement Number: S013
• Date Received: 08/16/2016
• Decision Date: 09/08/2016
• Product Code: NAH
• Advisory Committee: Immunology
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Additional vendor for the goat anti-mouse lgG antibody used in the manufacture of the Alere NMP22® BladderChek® Test procedural control line.