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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
Generic Namesystem, nucleic acid amplification, mycobacterium tuberculosis complex
Regulation Number866.3372
ApplicantGEN-PROBE, INC.
10210 genetic center dr.
san diego, CA 92121
PMA NumberP940034
Supplement NumberS004
Date Received01/24/1997
Decision Date05/15/1998
Reclassified Date 06/23/2014
Product Code MWA 
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
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.