GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)

FDA premarket approval P940034/S004 · decided 1998-05-15

Approval details

PMA number

P940034

Supplement

S004

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)

Generic name

System, nucleic acid amplification, mycobacterium tuberculosis complex

Applicant

Gen-Probe, Inc.

Date received

1997-01-24

Decision date

1998-05-15

Days to decision

476 days

Decision code

APPR

Product code

MWA

Advisory committee

Microbiology

Expedited review

No

Location

San Diego, CA

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, de

510(k) clearances by this applicant