WARNING LETTER
Sonrisa Family Dental dba www.mycovidtest19.com
MARCS-CMS 607748 —
June 15, 2020
Product:
Medical Devices
Recipient:
Recipient Name
Dr. Jason Korkus, DDS
Sonrisa Family Dental dba www.mycovidtest19.com
3520 South Morgan Street #207
Chicago
,
IL
60609
United States
questions@sfdchicago.com
Jason.korkus@gmail.com
info@sfdchicago.com
Issuing Office:
Center for Devices and Radiological Health
United States
WARNING LETTER
Date:  June 15, 2020
RE: Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
This is to advise you that the United States Food and Drug Administration (FDA) reviewed your websites at the Internet address www.mycovidtest19.com on June 15, 2020. We have also reviewed your social media page at www.facebook.com/Mycovid19Club.com where you direct consumers to your website, www.mycovidtest19.com. The FDA has observed that your website offers “Cellex Test Kit” and “Leccurate Test Kit” products for sale in the United States directly to consumers for at-home use. Based on our review, these products are intended for use in the mitigation, prevention, treatment, diagnosis or cure COVID-191 in people, and thus are devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the “Act”), 21 U.S.C. § 321(h).
The “Cellex Test Kit” and “Leccurate Test Kit” are offered for sale and distributed in the United States directly to consumers for at-home use without marketing approval, clearance, or authorization from FDA.2 Accordingly, these products are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have approved applications for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or approved applications for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). Your products are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the Agency of its intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). The introduction or delivery for introduction of these products into interstate commerce is prohibited under section 301(a) of the Act, 21 U.S.C. § 331(a). In addition, it is a prohibited act under section 301(k) of the Act, 21 U.S.C. § 331(k), to do any act with respect to a device while the device is held for sale after shipment in interstate commerce and results in the device being misbranded.
There is currently a global outbreak of respiratory disease caused by a novel coronavirus that has been named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2). The disease caused by the virus has been named “Coronavirus Disease 2019” (COVID-19). On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS.3 In addition, on March 13, 2020, the President declared a national emergency in response to COVID-19.4 Therefore, FDA is taking urgent measures to protect consumers from certain products that, without approval, clearance, or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. As described below, you sell products that are intended for use in the mitigation, prevention, treatment, diagnosis, or cure COVID-19 in people. We request that you take immediate action to cease the sale of such unapproved, uncleared, and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.
We remind you that, to date, FDA has not approved, cleared, or authorized any COVID-19 serology test for at-home testing. Different and potentially serious public health risks are presented with testing in the home versus a healthcare setting. Such risks include, but are not limited to, whether a lay person has the ability to collect their specimen, run the test, and interpret the test result accurately. Your website, www.mycovidtest19.com, indicates that the Cellex Test Kit and Leccurate Test Kit may be purchased directly by consumers and are intended to be used for at-home testing for COVID-19, including:
• “MyCOVID19 Testing Club includes 15 minute Covid tests for the whole family!”
• “This kit can be used for up to a year.  20 individual test kits.  Use for your family now and when the COVID returns in the Fall.”
• “Call or email your primary care physician for a Telemedicine visit to discuss how to use the kit and if they want you to make an appointment.”
• The “Recommendations and Instructions” page on your website directs individuals who purchase tests from your firm to “read the instruction for use carefully before performing the test” and provides links to retail outlets (including CVS and Walgreens) for the purchase of lancets (which are not included with the Cellex Test Kit and the Leccurate Test Kit). Reminding consumers to purchase their own lancets to conduct the test further demonstrates that such testing is intended to be performed at home.
• The “Recommendations and Instructions” page also recommends that “at home testers. . . should report suspect COVID-19 cases immediately (within 3 hours) to their local health department.
Your products are also misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because your webpage represents that the products sold on your website are “FDA approved” using the FDA logo. This representation creates a false impression that your products have been approved by FDA and is misleading. As discussed above, your products have not been approved by FDA. In addition, the FDA logo is for the official use of the FDA and not for use on private sector materials. Such use may send a misleading message that the FDA favors or endorses your products. Unauthorized use of the FDA logo may violate federal law and subject those responsible to civil and/or criminal liability.
For more information about FDA’s regulation of devices used to mitigate, prevent, treat, diagnose, or cure COVID-19; frequently asked questions; and other helpful resources, visit our website at https://www.fda.gov/medical-devices/emergency-situations-medical-devices/medical-devices-and-covid-19-pandemic. In addition, the guidance titled “Policy for Coronavirus Disease 2019 Tests During the Public Health Emergency (Revised)”5 provides information about FDA’s policies intended to help expand testing capacity by facilitating the development and use of COVID-19 tests during the public health emergency.
You should take immediate action to correct the violations cited in this letter. The violations cited in this letter are not meant to be an all-inclusive list. It is your responsibility to ensure that the products you sell are in compliance with the FD&C Act and FDA's implementing regulations. We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not representing your products for a COVID-19 related use for which they have not been approved, cleared, authorized, or exempted from premarket notification requirements by FDA, and that you do not make claims that misbrand the products in violation of the FD&C Act. Within 48 hours, please send an email to COVID-19-Task-Force-CDRH@fda.hhs.gov describing the specific steps you have taken to correct these violations.. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Failure to immediately correct the violations cited in this letter may result in legal action, including, without limitation, seizure and injunction.
FDA is advising consumers not to purchase or use certain products that are not in compliance with FDA requirements and are being misleadingly represented as safe and/or effective for the treatment or prevention of COVID-19. Your firm will be added to a published list on FDA's website of firms and websites that have received warning letters from FDA concerning the sale or distribution of COVID-19 related products in violation of the FD&C Act. This list can be found at https://www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-2019-covid-19-products. Once you have taken corrective actions and such actions have been confirmed by the FDA, the published list will be updated to indicate that your firm has taken appropriate corrective action.
If you cannot complete corrective action within 48 hours, state the reason for the delay and the time within which you will complete the corrections. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
Please direct any inquiries to FDA at COVID-19-Task-Force-CDRH@fda.hhs.gov.
Sincerely,
/S/
Timothy T. Stenzel, M.D., Ph.D.
Director
OHT7: Office of In Vitro Diagnostics and Radiological Health
Office of Office of Product Evaluation and Quality
Center for Devices and Radiological Health
______________
1 COVID-19 is the official name for the disease that is causing the 2019 novel coronavirus outbreak, first identified in Wuhan, China.
2 The “Cellex Test Kit” offered for sale on your website appears to be qSARS-CoV-2 IgG/IgM Rapid Test manufactured by Cellex Inc. On June 12, 2020 FDA re-issued an Emergency Use Authorization (EUA) issued on April 1, 2020, pursuant to section 564 of the Act, 21 U.S.C. § 360bbb-3, to permit emergency use of Cellex Inc.’s qSARS-CoV-2 IgG/IgM Rapid Test by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform moderate and high complexity tests for the qualitative detection of IgM and IgG antibodies against SARS-CoV-2, in serum, plasma (EDTA or citrate), or venipuncture whole blood from individuals suspected of COVID-19 by their healthcare provider. However, this EUA does not authorize the sale of the qSARS-CoV-2 IgG/IgM Rapid Test manufactured by Cellex Inc. directly to consumers for at-home testing.
3 Secretary of Health and Human Services Alex M. Azar II, Determination that a Public Health Emergency Exists. Jan. 31, 2020. (Accessible at https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx). The declaration was renewed for another 90 days on April 21, 2020. Secretary of Health and Human Services Alex M. Azar II, Renewal of Determination that a Public Health Emergency Exists. April 21, 2020. (Accessible at https://www.phe.gov/emergency/news/healthactions/phe/Pages/covid19-21apr2020.aspx).
4 President Donald J. Trump, Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19). Mar. 13, 2020. (Accessible at https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/).
5 Accessible at https://www.fda.gov/media/135659/download.
Content current as of:
06/17/2020
Regulated Product(s)
Medical Devices