[Federal Register Volume 62, Number 55 (Friday, March 21, 1997)]
[Notices]
[Pages 13652-13653]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-7134]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 97M-0082]
Behring Diagnostics, Inc.; Premarket Approval of EMIT
2000 Cyclosporine Specific Assay
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 Behring Diagnostics, Inc., San Jose, CA,
for premarket approval, under the Federal Food, Drug, and Cosmetic Act
(the act), of the EMIT 2000 Cyclosporine Specific Assay.
After reviewing the recommendation of the Clinical Chemistry and
Toxicology Devices Panel, FDA's Center for Devices and Radiological
Health (CDRH) notified the applicant, by letter of October 2, 1996, of
the approval of the application.
DATES: Petitions for administrative review by April 21, 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: Cornelia B. Rooks, Center for Devices
and Radiological Health (HFZ-440), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-443-2436.
SUPPLEMENTARY INFORMATION: On June 29, 1992, Syva Co., San Jose, CA
95161-9013, submitted to CDRH an application for premarket approval of
the EMIT 2000 Cyclosporine Specific Assay. The device is a
homogeneous enzyme immunoassay and is indicated for in vitro diagnostic
use on the Roche
[[Page 13653]]
Diagnostic Systems chemistry systems (i.e., COBAS MIRA ,
COBAS MIRA S, and COBAS MIRA Plus) for the
quantitative analysis of cyclosporine (CsA) in human whole blood as an
aid in the management of cyclosporine therapy in kidney, heart, and
liver transplant patients.
On November 16, 1992, the Clinical Chemistry and Toxicology Devices
Panel of the Medical Devices Advisory Committee, an FDA advisory
committee, reviewed and recommended approval of the application. On
October 2, 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 April 21, 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. 97-7134 Filed 3-20-97; 8:45 am]
BILLING CODE 4160-01-F
