[Federal Register Volume 59, Number 156 (Monday, August 15, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-19925]


[[Page Unknown]]

[Federal Register: August 15, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94M-0248]

 

PB Diagnostic Systems, Inc.; Premarket Approval of OPUS 
CEA

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 PB Diagnostic Systems, Inc., Westwood, 
MA, for premarket approval, under section 515 of the Federal Food, 
Drug, and Cosmetic Act (the act), of OPUS CEA. FDA's Center 
for Devices and Radiological Health (CDRH) notified the applicant, by 
letter on June 20, 1994, of the approval of the application.

DATES: Petitions for administrative review by September 14, 1994.

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, rm. 
1-23, 12420 Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Peter E. Maxim, Center for Devices and 
Radiological Health (HFZ-440), Food and Drug Administration, 1390 
Piccard Dr., Rockville, MD 20850, 301-594-1293.

SUPPLEMENTARY INFORMATION: On May 1, 1992, PB Diagnostic Systems, Inc., 
Westwood, MA 02090, submitted to CDRH an application for premarket 
approval of OPUS CEA. The device is an enzyme immunoassay and 
is indicated for the quantitative measurement of carcinoembryonic 
antigen (CEA) in serum to be used as an aid in the prognosis and 
management of cancer patients in whom changing concentrations of CEA 
are observed. In accordance with the provisions of section 515(c)(2) of 
the act as amended by the Safe Medical Devices Act of 1990, this 
premarket approval (PMA) was not referred to the Immunology Devices 
Panel, an FDA advisory panel, for review and recommendation because the 
information in the PMA substantially duplicates information previously 
reviewed by this panel.
    On June 20, 1994, 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 (21 
U.S.C. 360e(g)), for administrative review of CDRH's decision to 
approve this application. A petitioner may request either a formal 
hearing under part 12 (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 
Sec. 10.33(b) (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 
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 September 14, 1994, 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 Center for Devices and Radiological Health (21 
CFR 5.53).

    Dated: July 29, 1994.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 94-19925 Filed 8-12-94; 8:45 am]
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