[Federal Register Volume 61, Number 131 (Monday, July 8, 1996)]
[Notices]
[Pages 35771-35772]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17235]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96M-0218]


Adeza Biomedical Corp.; Premarket Approval of Fetal Fibronectin 
Enzyme Immunoassay Kit

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 Adeza Biomedical Corp., Sunnyvale, CA, 
for premarket approval, under the Federal Food, Drug, and Cosmetic Act 
(the act), of Fetal Fibronectin Enzyme Immunoassay Kit. After reviewing 
the recommendation of the Clinical Chemistry and Clinical Toxicology 
Devices Panel, FDA's Center for Devices and Radiological Health (CDRH) 
notified the applicant, by letter of September 29, 1995, of the 
approval of the application.

DATES: Petitions for administrative review by August 7, 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: Cornelia B. Rooks, Center for Devices 
and Radiological Health (HFZ-440), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 301-594-1243.

SUPPLEMENTARY INFORMATION: On October 31, 1994, Adeza Biomedical Corp., 
Sunnyvale, CA 94089, submitted to CDRH an application for premarket 
approval of Fetal Fibronectin Enzyme Immunoassay Kit. The device is to 
be used as an aid in assessing the risk of preterm delivery in 
<SUP>ls-thn-eq 7 days or <SUP>ls-thn-eq 14 days from the time of sample 
collection in pregnant women with signs and symptoms of early preterm 
labor, intact amniotic membranes, and minimal cervical dilatation (< 3 
centimeters), sampled between 24 weeks, 0 days and 34 weeks, 6 days 
gestation.
    The negative predictive values of 99.5 percent and 99.2 percent, 
for delivery in <SUP>ls-thn-eq 7 and <SUP>ls-thn-eq 14 days 
respectively, make it highly likely that delivery will not occur in 
these timeframes. In addition, although the positive predictive values 
were found to be 12.7 percent and 16.7 percent for delivery in 
<SUP>ls-thn-eq 7 and <SUP>ls-thn-eq 14 days, respectively, this 
represents an approximate 4-fold increase over the reliability of 
predicting delivery given no test information.
    On April 6, 1995, the Clinical Chemistry and Clinical Toxicology 
Devices Panel of the Medical Devices Advisory Committee, an FDA 
advisory committee, reviewed and recommended approval of the 
application.
    On September 29, 1995, CDRH approved the application by a letter to

[[Page 35772]]

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 part 12 (21 CFR 
part 12) of FDA's administrative practices and 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 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 August 7, 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: June 21, 1996.
Joesph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 96-17235 Filed 7-5-96; 8:45 am]
BILLING CODE 4160-01-F