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U.S. Department of Health and Human Services

CDRH Advisory Meeting Materials Archive

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Name of CommitteeImmunology Devices Panel
Date and TimeThe meeting was held on the following dates:
Dec 3, 08 8:30 AM - 5:00 PM
LocationHilton Washington DC North/Gaithersburg, Salons A, B and C
620 Perry Pkwy.
Gaithersburg , MD
Contact InformationDai J. Li, Center for Devices and Radiological Health (HFZ–440), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 240–276–0997, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512516. Information can be found on the FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512516. Please call the Information Line or access this Internet page for up-to-date information on this meeting.
AgendaThe committee will discuss and make recommendations on the premarket notification application for the Fujirebio HE4 EIA kit and associated Risk of Malignancy algorithm (ROMATM) Test. The HE4 EIA is an enzyme immunometric assay for the quantitative determination of HE4 in human serum. The HE4 EIA, used in conjunction with the ARCHITECT CA 125 II assay, creates a predictive probability of epithelial ovarian cancer using a mathematical function referred to as the ROMATM, for use in premenopausal and postmenopausal women presenting with an adnexal mass who have already been referred to an oncologic specialist and are scheduled for surgery. Subjects categorized as low risk for epithelial ovarian cancer using the ROMATM value may have surgical intervention performed by a non-oncology specialist. The results must be interpreted in conjunction with other clinical findings in accordance with standard clinical management guidelines. The assay is not indicated as an aid in a decision to proceed to surgery. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on the year 2008 and scroll down to the appropriate advisory committee link.
ProcedureInterested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before November 19, 2008. Oral presentations from the public will be scheduled for approximately 30 minutes at the beginning of committee deliberations and for approximately 30 minutes near the end of the deliberations. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before November 11, 2008. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by November 12, 2008.
 Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.
ConductFDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/ for procedures on public conduct during advisory committee meetings.
Related Documents
Agenda:Final Agenda for December 3, 2008 MeetingPDF
Brief Summary:Brief Summary for December 3, 2008 MeetingText
Briefing:Briefing Information for December 3, 2008 MeetingText
Questions:Questions for December 3, 2008 MeetingPDF
Roster:Final Roster for December 3, 2008 MeetingPDF
Transcript:Part 1PDF
Transcript:Part 2PDF
Transcript:Part 3PDF
Transcript:Part 4PDF
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
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