T-SPOT. TB Test

FDA Premarket Approval P070006 S012

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 extension of the shelf life of the t-spot. Tb50 kit, including panel a, panel b, and positive control, from 12 months to 18 months.

DeviceT-SPOT. TB Test
Generic NameMycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-linked Immunospot Test
ApplicantOXFORD IMMUNOTEC,LTD.
Date Received2019-12-05
Decision Date2020-03-03
PMAP070006
SupplementS012
Product CodeOJN 
Advisory CommitteeMicrobiology
Supplement TypeReal-time Process
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address OXFORD IMMUNOTEC,LTD. 94c Innovation Drive milton Park, Abingdon Oxfordshire OX14

Supplemental Filings

Supplement NumberDateSupplement Type
P070006Original Filing
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 IDPMASupp
15051716000053 P070006 006
15051716000022 P070006 006
15051716000022 P070006 006
15051716000053 P070006 006
15051716000046 P070006 007
15051716000046 P070006 007
15051716000305 P070006 011
15051716000305 P070006 011
15051716000008 P070006 011
15051716000008 P070006 011

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