Inspections, Compliance, Enforcement, and Criminal Investigations
Access Genetics 29-Jul-05
Department of Health and Human Services
Public Health Service
2098 Gaither Road
JULY 29, 2005
Via Federal Express
Ronald McGlennen M.D., President
7159 Shady Oak Rd .
Eden Prairie, MN 55344
Dear Dr. McGlennen:
The Office of In Vitro Diagnostic Devices (OIVD) has reviewed information on your website, http://www.access-genetics.com about several genetic tests: Thrombophilia Tests (Factor 5 Leiden, Factor 2 Prothrombin, MTHFR), Human Papillomavirus (HPV),Chlamydia & Gonorrhea PAP and Cystic Fibrosis. This review has revealed serious
regulatory problems involving theses devices manufactured by your firm.
Our review indicates that each of these products 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, your website states that "Access Genetics' CT-NG PAP Test uses leading-edge testing methods and exclusive webenabled reporting technology for the real-time detection, diagnosis and prognosis of CT-NG." In addition, your website states that, for example, "Each Test Package contains all the consumables, reagents and controls needed to perform the DNA extraction and chemistry for CT-NG PAP tests. It includes a Lab Assay Protocol and custom process templates that guide remote laboratory technicians in preparing and sending test assay results to Access Genetics' pathologists."
A review of our records shows no clearance or approval for your genetic assays. The assays therefore are adulterated under section 501(f)(1)(B) of the Act, in that they are not the subject of approved premarket approval applications under section 515(a) of the Act or approved applications for investigational device exemptions under section 520(g). These devices are also misbranded under section 502(o) of the Act because you did not notify FDA of your intent to introduce these devices into commercial distribution as required by section 510(k) of the Act. 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). The kind of information you need to submit to FDA for premarket review of your product is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. To discuss specific details of a premarket submission, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0484.
This letter is not intended to be an all-inclusive list of deficiencies associated with your devices. 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