Inspections, Compliance, Enforcement, and Criminal Investigations
Tepnel Diagnostics Ltd. 26-Aug-05
Department of Health and Human Services
Public Health Service
2098 Gaither Road
AUG 26 2005
Via Federal Express
Dr. Allan Swift
Tepnel Diagnostics Ltd.
12 Blacklands Way
United Kingdom OX14 1DY
Dear Dr. Swift:
The Office of In Vitro Diagnostic Devices (OIVD) has reviewed information on your Elucigene™ Brand Internet website, http://www.elucigene.com/products.html, about several devices manufactured by Tepnel Diagnostics that are marketed as analyte specific reagents (ASRs): the gel-based ELUCIGENE genetic assays CF-HT, CF29, CF poly-T, CF7, Ashplex 1, Ashplex 2, Gaucher, and TRP. 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.
According to your instructions for use/methods for use, each of the gel-based ELUCIGENE™ genetic assays is intended for "in vitro diagnostic use" to detect various human genetic mutations. In addition, a press release issued by ELUCIGENE on March 17, 2005 claimed that, "the ELUCIGENE™ family of kits for In Vitro Diagnostic use provide laboratories simple and cost effective assays for use in genetic screening programs. Industry-leading ELUCIGENE™ kits are available for the genetic analysis of human diseases such as cystic fibrosis and cardiovascular disease . . . ." As already indicated, Elucigene's website indicates that it offers products that are ASRs. ASRs are defined as "antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens." 21 CFR 864.4020(a) . ASRs are restricted devices. Among the restrictions on ASRs is a requirement that advertising and promotional materials for ASRs may not "make any statements regarding analytical and clinical performance." 21 CFR 809.30(d)(4).
Based on information on your website, these devices do not adhere to the restrictions on the sale, distribution, and use of ASRs. Your website makes specific analytical and performance claims such as that your devices can detect multiple mutations per device and screen for particular diseases. Statements on your website describing your devices indicate that they are intended for the detection of mutations related to a clinical diagnosis of, for example, Cystic Fibrosis, Tay Sachs Disease, and the risk for venous thromboembolism . In addition, the Instructions/Methods for Use supplied for your assays, provide detailed procedures (along with directions and guidelines for the interpretation of results) that are unique for your assays and that constitute analytical and performance claims. Furthermore, your CF-HT assay is marketed for use with your CFHT Results Reporter software. Such software also, as described, does not meet the definition of an ASR.
A review of our records shows no clearance or approval for your gel-based ELUCIGENE™ genetic assays or your CF-HT Results Reporter software. These devices are therefore adulterated under section 501(f)(1)(B) of the Act because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, or an approved application for investigational device exemption (IDE) under section 520(g) of the Act These devices are also misbranded under section 502(o), because you did not notify the agency of your intent to introduce the device into commercial distribution 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 PMA 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