[Federal Register Volume 62, Number 237 (Wednesday, December 10, 1997)]
[Notices]
[Pages 65084-65085]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-32216]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97M-0501]


Abbott Laboratories; Premarket Approval of IMx<Register> PSA and 
AxSYM<Register> PSA Assays

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing its 
approval of the supplemental application by Abbott Laboratories, 
Diagnostics Div., Abbott Park, IL, for premarket approval, under the 
Federal Food, Drug, and Cosmetic Act (the act), of the IMx<Register> 
PSA and AxSYM<Register> PSA assay. FDA's Center for Devices and 
Radiological Health (CDRH) notified the applicant, by letter of August 
7, 1997, of the approval of the supplemental application.

DATES: Petitions for administrative review by January 9, 1998.

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 November 2, 1994, Abbott Laboratories, 
Diagnostics Div., Abbott Park, IL 60064, submitted to CDRH a 
supplemental application for premarket approval of IMx<Register> PSA 
and AxSYM<Register> PSA assays. The devices are microparticle enzyme 
immunoassays (MEIA) for the quantitative measurement of Prostate 
Specific Antigen (PSA) in human serum as an aid in the detection of 
prostate cancer when used in conjunction with digital rectal exam (DRE) 
in men aged 50 years or older. Prostatic biopsy is required for 
diagnosis of cancer.
    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 Devices 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 August 7, 1997, CDRH approved the supplemental application by a 
letter to the applicant from the Deputy Director of Clinical and Review 
Policy, 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 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

[[Page 65085]]

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 January 9, 1998, 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 31, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 97-32216 Filed 12-9-97; 8:45 am]
BILLING CODE 4160-01-F