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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Toxicology Associates, Inc 16-May-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




VIA FEDERAL EXPRESS

Mr. Ben Corpus
Toxicology Associates, Inc.
999 Bethel Road
Columbus, OH 43214

Re : Quidel QuickVue In-line Strep Infectious Mononucleosis tests

WARNING LETTER

Dear Mr. Corpus:

The Office of In Vitro Diagnostics (OIV) in the Center for Devices and Radiological Health (CDRH) has reviewed information on your website, www.toxassociates.com, regarding the Quidel Quick Vue Influenza A/B, Quidel QuickVue Strep A, and Quidel QuickVue+Infectious Mononucleosis test. This review has revealed serious regulatory problems involving these devices marketed by your firm.The Quidel QuickVue tests identified above are devices withinin the meaning of Section 201(h) of the Federal Food, Drug, and Cosmetic Act (FDCA or Act) [21 U.S.C. 321(h)] because they are intended for use in the diagnosis of disease or other conditions, or treatment, prevention, or mitigation of disease.

The subject tests are cleared by FDA for the professional and laboratory use:

  • The Quidel QuickVue Influenza A/B Test is intended is intended for the rapid, qualitative detection of influenza Types A and B antigen directly from nasal swab, nasal wash and/or nasal aspirate specimens. The test is intended for use as an aid in the rapid diagnosis of acute virus infection. The test is intended for professional and laboratory use.

  • The Quidel QuickVue In-Line Strep A Test allows for the rapid detection of Group A Streptococcal antigen directly fro the patient throat swab specimens. The test is intended for use as an aid in the diagnosis of Group A Streptococcal infection, and is intended for use by healthcare professionals.

  • The Quidel QuickVue+ Infectious Mononucleosis test is a rapid color immunochromatographic assay (CICAa) for the detection of Infections Mononucleosis IgM heterophile antibodies in whole blood. This test is intended for use as an aid in the diagnosis
    of Infectious Mononucleosis. For use by healthcare professionals.

The information on your website, however , indicates that you are marketing these devices for Over-the- Counter (OTC) sale directly to the public . For example, your website states under the heading Influenza Home Test Kits, that "The influenza home test kit is available today for you to test yourself for the absence or presence of the flu virus. Keep you and your loved ones healthy by practicing preventive medicine."

A review of our records shows that you o not have marketing clearance or approval from the FDA for OTC sale of these products. Therefore, you are violating the law. Your products are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), in that they are class III devices under section 513(f), 21 U.S.C. 360c(f), and you do no have an approved application for premarket approval (PMA) in effect pursuant to section 515(a), 21 U. S.C. 360e(a), or an approved application for investigational device exemption under section 520(g), 21 U.S.C. 360j(g). The products are also misbranded under section 502(o), 21 U.S.C. 352(o), because a notice or other information was not provided to the FDA as required by section 510(k), 21 U.S.C. 360(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 premarket approval application (PMA) is pending before the agency. 21 CFR 807.81(b).

Your device is also misbranded under section 502(a) of the Act [21 U.S.C. 352(a)] in that the labeling of the device, namely your website, contains statements that are misleading in accordance with 21 CFR 807.97, because such statements create an impression of official approval of a device due to clearance of a premarket notification submission. Specifically, the labeling states the tests at issue have been approved by FDA. These devices were not approved by the FDA, but were determined to be substantially equivalent within the meaning of section 513(i)(1)(A) of the Act, 21 U.S.C. 360c(i)(1)(A).

On January 9, 2006, OIVD sent a letter to your company stating that it had come to our attention that you were marketing the above referenced tests as OTC and that we were unable to identify any FDA clearance for OTC sale of the devices from you or the manufacturer, Quidel Corp. The letter requested that you respond to OIVD with an explanation of why you were not required to obtain FDA clearance.

One March 8, 2006, we attempted to contact you in regards to January 9th letter. A message was left on your answering service requesting a response to that letter.

One April 3, 2006, we again contacted you about the January 9th letter. At this letter. At this time, we spoke to you personally and requested a response in writing. You stated that you would respond in one week's time. At you requested we faxed a copy of the original letter to you. To date we have not received any such response.

Requested Action

OIVD requests that Toxicology Associate Inc. immediately cease the dissemination of violative promotional materials for Quidel QuickVue Influenza A/B, Quidel QuickVue Strep A, and Quidel CARDS O.S. Mono tests that are the same as or similar to those described above, and that you revise the violative portions of your website. Please submit a written response to this letter 15 days after receipt, describing your intent to comply with this request, listing all promotional materials for Quidel QuickVue Influenza A/B, Quidel QuickVue Strep A, and Quidel CARDS O.S. Mono tests that are the same as or similar to those described above, and explaining your plan for discontinuing use of violative materials. If corrective action cannot within 15 days, state the reason for the delay and the time within which the corrections will be completed.

You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action being initiated by FDA without further notice. These actions include, but are not limited to, seizure, injunction, or civil money penalties. Also, Federal agencies are informed about Warning Letters we issue, such as this one, so they may consider this information when awarding government contracts.

The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for all medical devices you market comply with each applicable requirement of the of the Act and FDA implementing regulations. Failure to correct the violations discussed above may result in FDA regulatory action, including seizure or injunction, without further notice.

Please direct your response to Ms. Tara Goldman at the Food and Drug Administration, 2098 Gaither Rd., Rockville, M.D. 20850, facsimile at 240-276-0652. We remind you that only written communications are considered official.

Sincerely,

/S/

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