[Federal Register Volume 61, Number 223 (Monday, November 18, 1996)]
[Notices]
[Pages 58695-58696]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-29487]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96M-0423]
Dade Intl., Inc.; Premarket Approval of the aca plus
PSA Test Kit, aca plus PSA Calibrator, and aca plus
PSA Control
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 Dade Intl., Inc., Newark, DE, for
premarket approval, under the Federal Food, Drug, and Cosmetic Act (the
act), of the aca plus PSA Test Kit, aca plus PSA
Calibrator, and aca plus PSA Control. FDA's Center for
Devices and Radiological Health (CDRH) notified the applicant, by
letter of September 9, 1996, of the approval of the application.
DATES: Petitions for administrative review by December 18, 1996.
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: Peter E. Maxim, Center for Devices and
Radiological Health (HFZ-440), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 301-594-1293.
SUPPLEMENTARY INFORMATION: On February 1, 1996, Dade Intl., Inc.,
Newark, DE 19714, submitted to CDRH an application for premarket
approval of the aca plus PSA Test Kit, aca plus PSA
Calibrator, and aca plus PSA Control. The device is a
Prostate Specific Antigen (PSA) Test Kit, which consists of the PSA
test pack and reaction vessel used in the aca plus
immunoassay system to quantitatively measure PSA in human serum.
Measurements of PSA are used as an aid in the management of prostate
cancer patients.
In accordance with the provisions of section 515(c)(2) of the act
(21 U.S.C. 360e(c)(2)) as amended by the Safe Medical Devices Act of
1990, this premarket approval application (PMA) was not referred to the
Immunology Advisory Panel of the Medical Devices Advisory Committee, an
FDA advisory committee, for review and recommendation because the
information in the PMA substantially duplicates information previously
reviewed by this panel.
On September 9, 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 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
[[Page 58696]]
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 December 18, 1996, 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: October 24, 1996.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 96-29487 Filed 11-15-96; 8:45 am]
BILLING CODE 4160-01-F
