Warning Letter to Tepnel Diagnostics Ltd.
Via Federal Express
August 26, 2005
Dr. Allan Swift
Tepnel Diagnostics Ltd.
12 Blacklands Way
Abingdon, Oxon
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 CF-HT 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.
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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