T-SPOT TB TEST

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

FDA Premarket Approval P070006 S001

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.

Pre-market Approval Supplement Details

Approval for the use of t-cell xtend reagent with the t-spot. Tb test, in order to extend the time from sample collection to sample processing from within 8 hours of venipuncture to between 23 and 30 hours post venipuncture; and to make a technical correction to the t-spot. Tb test package insert to change the number of blood collection tubes required from (2) 6 ml heparin tubes to (1) 6 ml heparin tube. The t-cell xtend reagent is indicated for use with the t-spot. Tb test for the pre-treatment of whole blood prior to lymphocyte separation. The reagent aids in the removal of selected white blood cells from whole blood stored at room temperature (18-25 degrees c).

• 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: 2009-02-27
• Decision Date: 2010-07-09
• PMA: P070006
• Supplement: S001
• Product Code: OJN
• Advisory Committee: Microbiology
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: No
• Applicant Address: OXFORD IMMUNOTEC,LTD. 94c Innovation Drive milton Park, Abingdon Oxfordshire OX14

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