[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