Warning Letter to Access Genetics
Via Federal Express
August 1, 2005
Ronald McGlennen M.D., President
Access Genetics
7159 Shady Oak Rd.
Eden Prairie, MN 55344
Dear Dr. McGlennan:
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 these 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 web-enabled 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 applicationsunder 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 .
Sincerely,
Steven I. Gutman, M.D., M.B.A.
Director
Office of In Vitro Diagnostic Device Evaluation and Safety
Center
for Devices and Radiological Health
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