T SPOT-TB TEST
FDA premarket approval P070006 · decided 2008-07-30
Approval details
- PMA number
- P070006
- Trade name
- T SPOT-TB TEST
- Generic name
- Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test
- Applicant
- Oxford Immunotec, Ltd.
- Date received
- 2007-02-06
- Decision date
- 2008-07-30
- Days to decision
- 540 days
- Decision code
- APPR
- Product code
- OJN
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Milton Park, Abingdon Oxfordshire
- Statement
- APPROVAL FOR THE T-SPOT-TB. THIS DEVICE IS INDICATED FOR USE AS AN IN VITRO DIAGNOSTIC TEST FOR THE DETECTION OF EFFECTOR T CELLS THAT RESPOND TO STIMULATION BY MYCOBACTERIUM TUBERCULOSIS ANTIGENS ESAT-6 AND CFP-10 BY CAPTURING INTERFERON GAMMA (IFN-¿) IN THE VICINITY OF T CELLS IN HUMAN WHOLE BLOOD COLLECTED IN SODIUM CITRATE OR SODIUM OR LITHIUM HEPARIN. IT IS INTENDED FOR USE AS AN AID IN THE DIAGNOSIS OF M. TUBERCULOSIS INFECTION. T-SPOT-TB IS AN INDIRECT TEST FOR M. TUBERCULOSIS INFECTION (
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