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: S017
• Date Received: 05/03/2021
• Decision Date: 07/26/2021
• Product Code: OJN
• Advisory Committee: Microbiology
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval to include an additional manufacturing site establishment to perform manufacturing of the device.