Approval for changes to the package insert in lieu of a post-marketing study. The changes include addition of interpretive criteria from the center for disease control and prevention's july 7, 2000, mmwr "update: nucleic acid amplification test for tuberculosis" and the change of a precaution statement concerning negative test results to a warning statement. These changes will be provided in a technical bulletin that will accompany the package insert for the next 4-6 months until the next printing of the package insert.
| Device | GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST |
| Applicant | GEN-PROBE, INC. |
| Date Received | 2001-03-02 |
| Decision Date | 2001-08-30 |
| PMA | P940034 |
| Supplement | S012 |
| Advisory Committee | Microbiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Other Report |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | GEN-PROBE, INC. 10210 Genetic Center Dr. san Diego, CA 92121 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P940034 | | Original Filing |
| S019 |
2012-11-07 |
30-day Notice |
| S018 |
2010-03-31 |
30-day Notice |
| S017 |
2006-07-27 |
135 Review Track For 30-day Notice |
| S016 |
2004-09-21 |
30-day Notice |
| S015 |
2004-01-22 |
30-day Notice |
| S014 | | |
| S013 |
2001-12-18 |
Special (immediate Track) |
| S012 |
2001-03-02 |
Normal 180 Day Track |
| S011 |
2000-10-25 |
Real-time Process |
| S010 |
1999-05-12 |
30-day Notice |
| S009 |
1998-10-19 |
Special (immediate Track) |
| S008 |
1998-09-04 |
Panel Track |
| S007 |
1998-08-17 |
Normal 180 Day Track |
| S006 |
1997-09-15 |
Normal 180 Day Track |
| S005 |
1997-07-02 |
Normal 180 Day Track |
| S004 |
1997-01-24 |
Normal 180 Day Track |
| S003 |
1996-06-17 |
Normal 180 Day Track |
| S002 |
1996-05-22 |
Special (immediate Track) |
| S001 |
1996-02-23 |
Normal 180 Day Track |
NIH GUDID Devices