BEGIN:VCALENDAR
METHOD:PUBLISH
CALSCALE:GREGORIAN
PRODID:-//EVDB//www.eventful.com//EN
VERSION:2.0
X-WR-CALNAME:Immunology Devices Panel in Washington DC at Hilton Washi
	ngton DC/North Gaithersburg - Eventful
BEGIN:VEVENT
DTSTART:20081203T000000
DTEND:20081203T000000
DTSTAMP:20081202T234249Z
SUMMARY:Immunology Devices Panel
DESCRIPTION: Event Name: Immunology Devices Panel  Event Date(s): Wedn
	esday\, December 03\, 2008 to Wednesday\, December 03\, 2008  Event Lo
	cation: Hilton Washington DC North/Gaithersburg\, Gaithersburg\, Maryl
	and\, U.S.A.  Description: The committee will discuss and make recomme
	ndations on the premarket notification application for the Fujirebio H
	E4 EIA kit and associated Risk of Malignancy algorithm (ROMATM) Test. 
	The HE4 EIA is an enzyme immunometric assay for the quantitative deter
	mination of HE4 in human serum. The HE4 EIA\, used in conjunction with
	 the ARCHITECT CA 125 II assay\, creates a predictive probability of e
	pithelial ovarian cancer using a mathematical function referred to as 
	the ROMATM\, for use in premenopausal and postmenopausal women present
	ing with an adnexal mass who have already been referred to an oncologi
	c specialist and are scheduled for surgery. Subjects categorized as lo
	w risk for epithelial ovarian cancer using the ROMATM value may have s
	urgical intervention performed by a non-oncology specialist. The resul
	ts 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.  Sponsor:
	 FDA  Host Company: FDA  Contact Information: Phone: 240–276–0997 
	 Fax: n/a  Email: n/a
LOCATION:Hilton Washington DC/North Gaithersburg @ Maryland, United St
	ates
SEQUENCE:1228261369
UID:E0-001-017491994-5
URL:http://eventful.com/E0-001-017491994-5
END:VEVENT
END:VCALENDAR