This device, a target-amplified nucleic acid probe test, is indicated for: the in vitro diagnostic detection of mycobacterium tuberculosis complex rrna in acid-fast bacilli (afb) smear positive and negative concentrated sediments prepared from sputum (induced or expectorated), bronchial specimens (e. G. , bronchalveolar lavages or bronchial aspirates) or tracheal aspirates. The mtd test is intended for use only with specimens from patients showing signs and symptoms consistent with active pulmonary tuberculosis. Mtd is to be used as an adjunctive test for evaluating either afb smear positive or negative sediments prepared using nalc-naoh digestion-decontamination of respiratory specimens. Patients who are suspected of having pulmonary tb based on clinical evaluation and who have received no antituberculous therapy, less than 7 days of such therapy, or have not received such therapy in the last 12 months may be evaluated with this test. The mtd test should be performed only in laboratories proficient in the culture and identification of m. Tuberculosis (level ii and iii or extent 3 and 4). The mtd test must be performed in conjunction with mycobacterial culture.
| Device | GEN-PROBE(R) AMPLIFIED(TM) MYCOBACTERIUM TUBERCULOSIS DIRECT (MTD) TEST |
| Applicant | GEN-PROBE, INC. |
| Date Received | 1998-09-04 |
| Decision Date | 1999-09-30 |
| Notice Date | 2000-02-15 |
| PMA | P940034 |
| Supplement | S008 |
| Docket Number | 00M-0578 |
| Advisory Committee | Microbiology |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | GEN-PROBE, INC. 10210 Genetic Center Dr. san Diego, CA 92121 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
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