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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameGEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)
Classification Namesystem, nucleic acid amplification, mycobacterium tuberculosis complex
Generic Nametarget amplification test for the direct detection of mycobacterium tuberculosis
Regulation Number866.3372
ApplicantGEN-PROBE, INC.
PMA NumberP940034
Supplement NumberS004
Date Received01/24/1997
Decision Date05/15/1998
Product Code
MWA[ Registered Establishments with MWA ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
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.
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