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When
Dec 3, 2008 (Wednesday)
Where
Who
No performers specified
What
Event Name: Immunology Devices Panel Event Date(s): Wednesday, December 03, 2008 to Wednesday, December 03, 2008 Event Location: Hilton Washington DC North/Gaithersburg, Gaithersb...
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Event details: Immunology Devices Panel
Description
Event Name: Immunology Devices Panel
Event Date(s): Wednesday, December 03, 2008 to Wednesday, December 03, 2008
Event Location: Hilton Washington DC North/Gaithersburg, Gaithersburg, Maryland, U.S.A.
Description: The 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.
Sponsor: FDA
Host Company: FDA
Contact Information: Phone: 240–276–0997
Fax: n/a
Email: n/a
Event Date(s): Wednesday, December 03, 2008 to Wednesday, December 03, 2008
Event Location: Hilton Washington DC North/Gaithersburg, Gaithersburg, Maryland, U.S.A.
Description: The 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.
Sponsor: FDA
Host Company: FDA
Contact Information: Phone: 240–276–0997
Fax: n/a
Email: n/a
Cost
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