[Federal Register Volume 62, Number 117 (Wednesday, June 18, 1997)]
[Notices]
[Pages 33092-33093]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-15990]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97M-0184]


Gen-Probe, Inc.; Premarket Approval of Gen-
Probe Amplified Mycobacterium Tuberculosis Direct Test

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing its 
approval of the application by Gen-Probe, Inc., San Diego, 
CA, for premarket approval, under the Federal Food, Drug, and Cosmetic 
Act (the act), of the Gen-Probe Amplified Mycobacterium 
tuberculosis Direct Test (MTD). After reviewing the recommendation of 
the Microbiology Devices Panel, FDA's Center for Devices and 
Radiological Health (CDRH) notified the applicant, by letter on 
December 15, 1995, of the approval of the application.

DATES: Petitions for administrative review by July 18, 1997.

ADDRESSES: Written requests for copies of the summary of safety and 
effectiveness data and petitions for administrative review, to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Sharon L. Hansen, Center for Devices 
and Radiological Health (HFZ-440), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 301-594-2096.

SUPPLEMENTARY INFORMATION: On July 11, 1994, Gen-Probe, Inc., 
San Diego, CA, 92121, submitted to CDRH an application for premarket 
approval of the Gen-Probe Amplified MTD. The device is a 
target-amplified nucleic acid probe test for the in vitro diagnostic 
detection of M. tuberculosis complex rRNA in acid fast bacilli (AFB) 
smear positive concentrated sediments prepared from sputum (induced or 
expectorated), bronchial specimens (e.g., bronchoalveolar lavages or 
bronchial aspirates), or tracheal aspirates. The MTD test is intended 
for use as an adjunctive test for evaluating AFB smear positive 
concentrated 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). The MTD should always be performed in conjunction 
with a mycobacterial culture.
    On May 2, 1995, the Microbiology Devices Panel of the Medical 
Devices Advisory Committee, an FDA advisory committee, reviewed and 
recommended approval of the application. On December 15, 1995, CDRH 
approved the

[[Page 33093]]

application by a letter to the applicant from the Director of the 
Office of Device Evaluation, CDRH.
    A summary of the safety and effectiveness data on which CDRH based 
its approval is on file in the Dockets Management Branch (address 
above) and is available from that office upon written request. Requests 
should be identified with the name of the device and the docket number 
found in brackets in the heading of this document.

Opportunity for Administrative Review

    Section 515(d)(3) of the act (21 U.S.C. 360e(d)(3)) authorizes any 
interested person to petition, under section 515(g) of the act, for 
administrative review of CDRH's decision to approve this application. A 
petitioner may request either a formal hearing under 21 CFR part 12 of 
FDA's administrative practices and procedures regulations or a review 
of the application and CDRH's action by an independent advisory 
committee of experts. A petition is to be in the form of a petition for 
reconsideration under 21 CFR 10.33(b). A petitioner shall identify the 
form of review requested (hearing or independent advisory committee) 
and shall submit with the petition supporting data and information 
showing that there is a genuine and substantial issue of material fact 
for resolution through administrative review. After reviewing the 
petition, FDA will decide whether to grant or deny the petition and 
will publish a notice of its decision in the Federal Register. If FDA 
grants the petition, the notice will state the issue to be reviewed, 
the form of the review to be used, the persons who may participate in 
the review, the time and place where the review will occur, and other 
details.
    Petitioners may, at any time on or before July 18, 1997 file with 
the Dockets Management Branch (address above) two copies of each 
petition and supporting data and information, identified with the name 
of the device and the docket number found in brackets in the heading of 
this document. Received petitions may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.
    This notice is issued under the Federal Food, Drug, and Cosmetic 
Act (secs. 515(d), 520(h) (21 U.S.C. 360e(d), 360j(h))) and under 
authority delegated to the Commissioner of Food and Drugs (21 CFR 5.10) 
and redelegated to the Director, Center for Devices and Radiological 
Health (21 CFR 5.53).

    Dated: June 4, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 97-15990 Filed 6-17-97; 8:45 am]
BILLING CODE 4160-01-F