Inspections, Compliance, Enforcement, and Criminal Investigations
Creative Clinical Concepts, Inc. 10-Nov-05
Department of Health and Human Services
Public Health Service
2098 Gaither Road
November 10, 2005
Via Federal Express
Gordon E. Ens, BA, MT (ASCP), President
Creative Clinical Concepts, Inc.
210 St. Paul Street, Suite 200
Denver, CO 80206
Dear Mr. Ens:
The Office of In Vitro Diagnostic Devices (OIVD) has reviewed information on your website, http://www.aspirinworks.com, about your AspirinWorks test. This review has revealed serious regulatory problems involving this product manufactured by your firm.
The AspirinWorks test is a device under section 201(h) of the Food, Drug, and Cosmetic Act (FDCA or Act), 21 U.S.C. 321(h), because it is intended for use in the diagnosis of disease or other conditions, or in the cure, treatment, prevention, or mitigation of disease. For example, the fact sheet on your website states that "The effectiveness of aspirin in preventing heart attack and stroke is dependent on its ability to inhibit the production of ThromboxaneA2 via the cyclooxygenase pathway in the platelet : AspirinWorks® quantifies platelet function inhibition . . . ." In addition, this fact sheet contains a table that links urine ThromboxaneAZ concentration to a patient's risk for stroke, myocardial infarction, and death. This device is being offered for commercial distribution to laboratories across the United States and even directly to consumers via links and test order forms found on your website.
A review of our records shows that the AspirinWorks® test has not been approved or cleared for marketing. Therefore, it is adulterated under section 501(f)(1)(B) of the Act, in that it is a class III device under section 513(f) and it is not the subject of an approved premarket approval application under section 515(a) or an approved application for investigational device exemption under section 520(g). This device is also misbranded under section 502(o), because a notice or other information respecting it was not provided to the FDA as required by section 510(k). For a product requiring premarket approval before marketing, the notification required by section 510(k) of the Act is deemed to be satisfied when a premarket approval application is pending before the agency. 21 CFR 807.81(b)
This letter is not intended to be an all-inclusive list of deficiencies associated with your device. It is your responsibility to ensure adherence to each requirement of the Act and regulations for every FDA-regulated product that you market. You are responsible for investigating and reviewing all materials to ensure compliance with applicable regulations
You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, Federal agencies are informed about the Warning Letters we issue, such as this one, so that they may consider this information when awarding government contracts.
Please notify this office in writing within fifteen (15) working days of receipt of this letter, of the specific steps you have taken. to correct the noted violations, including an explanation of each step being taken to prevent the recurrence of similar violations. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Please direct your response to James Woods, Deputy Director of Patient Safety and Product Quality, Office of In Vitro Diagnostic Device Evaluation and Safety, 2098 Gaither Road, HFZ-440, Rockville, Maryland 20850.
Steven I. Gutman, M.D., M.B.A.
Office of In Vitro Diagnostic Device
Evaluation and Safety
Center for Devices and Radiological Health