Approval for the institution of the use of semi-automated system for the dispensing and capping stages in the production of the positive control, panel a reagent, and panel b reagent of the t-spot. Tb test kit using the ff30 dispenser/capper from flexicon. In addition, the type of vial caps has been changed from a popcan cap to a hdpe cap which is now gamma irradiated rather than autoclaved to reduce bacterial and fungal contamination.
| 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 | 2009-10-01 |
| Decision Date | 2010-03-04 |
| PMA | P070006 |
| Supplement | S003 |
| Product Code | OJN |
| Advisory Committee | Microbiology |
| Supplement Type | Real-time Process |
| 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