[Federal Register Volume 62, Number 62 (Tuesday, April 1, 1997)]
[Notices]
[Pages 15526-15527]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-8114]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 97M-0125]


Roche Molecular Systems, Inc.; Premarket Approval of 
AMPLICOR Mycobacterium Tuberculosis 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 Roche Molecular Systems, Inc., 
Somerville, NJ for premarket approval, under the Federal Food, Drug, 
and Cosmetic Act (the act), of the AMPLICOR (MTB) Test. After 
reviewing the recommendation of the Microbiology Devices Panel, FDA's 
Center for Devices and Radiological Health (CDRH) notified the 
applicant, by letter of November 26, 1996, of the approval of the 
application.

DATES: Petitions for administrative review by May 1, 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, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2096.

SUPPLEMENTARY INFORMATION: On December 22, 1994, Roche Molecular 
Systems, Inc., Somerville, NJ 08876-3711, submitted to CDRH an 
application for premarket approval of the AMPLICOR (MTB) 
Test. The device is a target amplified in vitro diagnostic test for the 
qualitative detection of M. tuberculosis complex DNA in concentrated 
sediments prepared from sputum (induced or expectorated), bronchial 
specimens including bronchoalveolar lavages or aspirates, or tracheal 
aspirates. The AMPLICOR MTB Test is intended for use as an 
adjunctive test for evaluating acid fast bacilli (AFB) smear positive 
sediments prepared using NALC-NaOH or NaOH digestion-decontamination of 
respiratory specimens from untreated patients suspected of having 
tuberculosis. Untreated patients are patients who have: (1) Received no 
antituberculosis therapy; (2) had less than 7 days of therapy; or (3) 
have not received such therapy in the last 12 months. Only untreated 
patients may be evaluated with the AMPLICOR MTB Test, which 
should only be performed in institutions proficient in the culture and 
identification of M. tuberculosis (ATS Level II and III or CAP extent 3 
and 4). The test should always be performed in conjunction with a 
mycobacterial culture.
    On January 25, 1996, the Microbiology Devices Panel of the Medical 
Devices Advisory Committee,

[[Page 15527]]

an FDA advisory committee, reviewed and recommended approval of the 
application. On November 26, 1996, CDRH approved the 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 May 1, 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: February 20, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 97-8114 Filed 3-31-97; 8:45 am]
BILLING CODE 4160-01-F