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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Prodesse, Inc. 09-Jan-06

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration


2098 Gaither Road
Rockville MD 20850

V ia Federal Express

January 9, 2006

Mr. Thomas M. Shannon
Prodesse, Inc.
W229 N1870 Westwood Drive
Waukesha, WI 53186

Re; ProFlu-1™, ProFneurrto-I ™, I-lexaplex®, Hexaplex® Plus, Pneumoplex®, Adenoplex®, Adenoplex®, Herpex Mplex ™, SARA/Coronaplex ™


Dear Mr. Shannon:

The Food and Drug Administration (FDA) has reviewed your Internet site, http://vvww.prodesse.com/product/Analyte.html regarding your firm's ProFlu-1™, ProPneumo-1™, Hexaplex®, Hexaplex® Plus, Adenoplex®,Herpes Mplex™ and SARS/Coronaplex™ Analyte Specific Reagents (ASRs). This review has revealed serious regulatory problems involving these devices manufactured by your firm.

Our review has determined that these reagents are medical devices as defined by Section 201(h) t)f the Federal Food Drug and Cosmetic Act (Act) U.S.C. 321(h), because they are intended for use in the diagnosis of disease or other conditions, or in the cure, treatment, prevention, or mitigation of disease.

We are concerned that, from descriptions on your website, the devices that you are promoting as ASRs do not appear to be stand-alone reagents intended for use in "a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens" - the definition of an ASR under 21 CFR 864.4020(a) (emphasis added). Your website states that, for example, the ProFlu-1 ASR is used for the detection of Influenza A, Influenza B, and RSV. Marketing products for the identification and quantification of multiple chemical substances goes beyond the limits of the definition of an ASR. Furthermore, your ivebsite describes these products as "assays" that also include internal controls. Complete assays are diagnostic. test kits and do not fall witflin the scope of thc ASR rule.

In addition, a press release on your website dated December 2, 2005 states that "ProFlu-1 is a Real Time multiplex PCR assay which detects and differentiates Influenza A, Influenza B and RSV. Hexaplex is a multiplex PCR assay which detects and differentiates Influenza A, Influenza B, RSV, Parainfluenza 1, Parainfluenza 2 and Parainfluenza 3. Hexaplex Plus detects seven viruses - the six detected in Hexaplex plus the newly discovered human metapneumovirus. All three assays are used by clinical labs around the world as they are the most sensitive commercial tests available for simultaneous detection of key respiratory viruses." This press release makes specific performance claims such as that your devices can detect multiple viruses per device and differentiate particular respiratory diseases, including avian influenza. 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).

Accordingly, these reagents are adulterated under section 501(f)(1)(I3) of the Act, in that they are class III devices under section 513(f) and you do not have approved applications for premarket approval in effect pursuant to section 515(a) or approved applications for investigational device exemption under section 520(g). It is also misbranded under section SU2(o), because a notices or other information respecting this device was not provided to the FDA as required by section 510(k). For products 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 (PMA) is pending before the agency. 21 GFR 807.81(b). The kind of information you need to submit to FDA to for premarket review of your product is described on the internet at http:/www.fda.gov/cdrh/devadvice/312.html. To discuss specific details of a premarket submission, please contact the Office of In Vitro Diagnostic Device Evaluation and safety at 240-276-04134.

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 with in 15 working days, state the reason for the delay and the time within which the corrections will he 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 yours,


Steven I. Gutman, M.D., M.B.A
Office of In Vitro Diagnostic Device
Evaluation and Safety
Center for Devices and Radiological Health