T SPOT-TB TEST

Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-linked Immunospot Test

FDA Premarket Approval P070006

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

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 (including disease) and is intended for use in conjunction with risk assessment, radiography and other medical and diagnostic evaluations.

• Device: T SPOT-TB TEST
• Classification Name: Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-linked Immunospot 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
• Notice Date: 2008-08-26
• PMA: P070006
• Supplement: S
• Product Code: OJN
• Docket Number: 08M-0477
• Advisory Committee: Microbiology
• Expedited Review: No
• Combination Product: No
• Applicant Address: OXFORD IMMUNOTEC,LTD. 94c Innovation Drive milton Park, Abingdon Oxfordshire OX14
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Approval Order: Approval Order

Supplemental Filings

Supplement Number	Date	Supplement Type
P070006		Original Filing
S017	2021-05-03	Normal 180 Day Track No User Fee
S016	2021-03-09	30-day Notice
S015
S014	2020-03-30	Normal 180 Day Track
S013	2020-03-10	30-day Notice
S012	2019-12-05	Real-time Process
S011	2013-02-19	135 Review Track For 30-day Notice
S010
S009	2012-09-04	135 Review Track For 30-day Notice
S008	2012-08-27	Real-time Process
S007	2011-11-17	Real-time Process
S006	2011-07-12	Normal 180 Day Track
S005	2011-04-06	30-day Notice
S004	2010-02-18	30-day Notice
S003	2009-10-01	Real-time Process
S002	2009-09-30	30-day Notice
S001	2009-02-27	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
15051716000053	P070006	006
15051716000022	P070006	006
15051716000046	P070006	007
15051716000305	P070006	011
15051716000008	P070006	011
05051716000186	P070006	015