Letter to Correlogic Systems, Inc.

DEPARTMENT OF HEALTH & HUMAN SERVICES
	Food and Drug Administration 2098 Gaither Road Rockville MD 20850 February 18, 2004

VIA FEDERAL EXPRESS

Peter J. Levine, Esq.
President and CEO
Correlogic Systems, Inc.
6701 Democracy Blvd. Suite 300
Bethesda, MD 20817

Dear Mr. Levine:

The Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) has reviewed reports indicating that Correlogic Systems is contemplating or has begun the commercial distribution to two major commercial laboratories of a test intended for use in detecting ovarian cancer. Under section 201(h) the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. § 321(h)), any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part or accessory, which is intended for use in the diagnosis of disease or other conditions is a device.

We have no record that such a test has been the subject of premarket review by FDA. We invite you to meet with us at your earliest convenience to discuss the nature and appropriate regulatory status of your technology, and the least burdensome ways that Correlogic Systems may fulfill any premarket review requirements that may apply.

Please contact me at (301) 594-3084 to set up a meeting. We are committed to working with you as we strive to protect the public health without unnecessarily imposing regulatory burdens on the marketing of products of potential clinical importance.

Sincerely yours,

/S/

Steven I. Gutman, M.D., M.B.A.
Office Director
Office of In Vitro Diagnostic Device Evaluation and Safety
Center for Devices and Radiological Health