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: T-SPOT®.TB Test
• Generic Name: Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
• Applicant: Oxford Immunotec, Ltd.; 94c Innovation Dr.; Milton Park, Abingdon Oxfordshire OX14 4RZ
• PMA Number: P070006
• Supplement Number: S021
• Date Received: 11/02/2023
• Decision Date: 12/04/2023
• Product Code: OJN
• Advisory Committee: Microbiology
• 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  
to eliminate ‘redundant’ testing of the of incoming kit components