Approval for:1)reagent manufacturing modifications that include reformulation of the specimen dilution buffer and enzyme dilution buffer reagents; packaging of the amplification reagent in one vial, a modified lyophilization cycle for the hybridization reagent, and an increased volume of reconstituion buffer provided; 2) kit configuration changes that include deletion of the termination reagent and hybridization controls; and 3)assay protocol changes that include use of increased sample size, decreased volume of specimen dilution buffer, reduced amplification time, increased selection time, and elimination of the termination step. The mtd test is indicated for the direct detection of mycobacterium tuberculosis complex rrna in evaluating afb smear positive sediments prepared using nalc-naoh digestion-decontamination of respiratory specimens from untreated patients suspected of having tuberculosis. Patients who have received no anti-tuberculous 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 laboratories). The mtd should always be performed in conjuction with mycobacterial culture.
| Device | GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST) |
| Classification Name | System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex |
| Generic Name | System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex |
| Applicant | GEN-PROBE, INC. |
| Date Received | 1997-01-24 |
| Decision Date | 1998-05-15 |
| PMA | P940034 |
| Supplement | S004 |
| Product Code | MWA |
| Advisory Committee | Microbiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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