WARNING LETTER
Ikcon Investments, Inc dba Ikcon Medical
MARCS-CMS 609791 —
March 25, 2021
Product:
Medical Devices
Recipient:
Recipient Name
Ricardo Emmanuel Weichsel Upton
Recipient Title
President
Ikcon Investments, Inc dba Ikcon Medical
14653 Caminito Lazanja
San Diego
,
CA
92127
United States
info@ikconmedical.com
Issuing Office:
Center for Devices and Radiological Health
United States
WARNING LETTER
Date: March 25, 2021
TO:
6540 Lusk Blvd Suite C-111
San Diego, CA 92121
University Center Lane, Suite 400
San Diego, CA 92122
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 addresses www.ikconmedical.com and www.akcutestshop.com on February 3, 4, and 11, 2021. The FDA has observed that your website, www.akcutestshop.com, offers the “Akcutest COVID-19 Antibody Test” (also referred to as the “Akcutest Kit (25 tests per Kit $20/test) COVID-19 Rapid Tests,” “Akcutest Sample Kit (3 tests per Kit $33/test) COVID-19 Rapid tests,” and “Akcutest Serological Rapid Test”) (hereafter referred to as “Akcutest Kit”) and the “Lumigenik COVID-19 Antigen Rapid Test” (also referred to as “Lumigenik Sample Kit (3 tests per Kit $50/test) COVID-19 Rapid Tests,” “Lumigenik Kit (25 tests per Kit $30/test) COVID-19 Rapid Tests,” and “Lumigenik Antigen Rapid Test”) (hereafter referred to as “Lumigenik Kit”) for sale in the United States. Based on our review, these products are intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19
1
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 Akcutest Kit and the Lumigenik Kit are offered for sale in the United States without marketing approval, clearance, or authorization from FDA. Accordingly, the 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 an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). The 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.
2
In addition, on March 13, 2020, there was a Presidential declaration of a national emergency in response to COVID-19.
3
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 above, you sell a product that is intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19 in people. We request that you take immediate action to cease the sale of any unapproved, uncleared, and unauthorized product for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.
The Akcutest Kit is also misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because its labeling is false or misleading. FDA registration of a device establishment or assignment of a registration number does not denote FDA approval of the establishment or the device. Thus, references to an establishment registration that create an impression of official FDA approval of the establishment or its products are misleading and constitute misbranding. See 21 CFR 807.39. Your websites reference FDA registration (e.g., “FDA registered”), at times incorporating unauthorized use of the FDA logo,
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alongside information about and photos of the Akcutest Kit. As displayed, such representations imply that FDA has approved, cleared, authorized, or otherwise evaluated the product. As stated above, FDA has not approved, cleared, or authorized the product. Moreover, the “disclaimer” presented, for example, in small font and placed at the very bottom of your websites stating that “[t]his test has not been reviewed by the FDA” could be easily overlooked and does not mitigate the overall impression that FDA has approved, cleared, authorized, or otherwise evaluated the product. We also note that based on our review of FDA’s Establishment Registration & Device Listing Database, an establishment with or including the name “Ikcon” is not registered and no device by the name of “Akcutest” was listed by any establishment. Therefore, statements indicating “FDA registered” also appear to be false. Your firm’s representations are especially concerning from a public health perspective because consumers rely on information provided by sellers to determine whether to purchase a device and your presentation conveys the misimpression that the products have been reviewed and approved by FDA.
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/coronavirus-covid-19-and-medical-devices
. In addition, the guidance titled “Policy for Coronavirus Disease 2019 Tests During the Public Health Emergency (Revised)”
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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 address the violations cited in this letter. This letter is not meant to be an all-inclusive list of violations that exist in connection with your product(s) or operations. It is your responsibility to ensure that the products you sell are in compliance with the Act and its implementing regulations. We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your product(s) as safe and/or effective for a COVID-19-related use for which they have not been approved, cleared, or authorized by FDA and that you do not make claims that adulterate or misbrand the product(s) in violation of the 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 address these violations. Include an explanation of each step being taken to prevent the recurrence of any violations, as well as copies of related documentation. Failure to immediately address this matter may result in legal action, including, without limitation, seizure and injunction.
FDA is advising consumers not to purchase or use certain products that have not been approved, cleared, or authorized by FDA and that are being misleadingly represented as safe and/or effective for the mitigation, prevention, treatment, diagnosis, or cure 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 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 actions to address the sale of your unapproved, uncleared, and unauthorized product(s) for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, and any appropriate corrective actions have been confirmed by the FDA, the published list will be updated to indicate that your firm has taken such corrective actions.
This letter notifies you of our concerns and provides you with an opportunity to address them. If you cannot take action to address this matter completely within 48 hours, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the 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 Stenzel, M.D., Ph.D.
Director
OHT7: Office of In Vitro Diagnostics and Radiological
Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
_________________________
1
As explained below, there is currently an outbreak of a respiratory disease named “Coronavirus Disease 2019” (COVID-19).
2
Secretary of Health and Human Services, Determination that a Public Health Emergency Exists (originally issued Jan. 31, 2020, and subsequently renewed), available at
https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx
.
3
Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak (Mar. 13, 2020), available at
https://trumpwhitehouse.archives.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/
.
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The FDA logo is for official use by FDA and not for private use on labeling of FDA-regulated products. See FDA Logo Policy (available at:
https://www.fda.gov/about-fda/website-policies/fda-logo-policy
).
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Accessible at
https://www fda.gov/media/135659/download
.
Content current as of:
04/15/2021
Regulated Product(s)
Medical Devices