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  5. AkivaMed Inc. - 609211 - 07/23/2020
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WARNING LETTER

AkivaMed Inc. MARCS-CMS 609211 —

Product:
Medical Devices
Recipient:
AkivaMed Inc.

United States

info@akivamed.com
Issuing Office:
Center for Devices and Radiological Health

United States

WARNING LETTER

Date: July 23, 2020

RE: Adulterated and Misbranded Products Related to Coronavirus Disease 2019

This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address www.akivamed.com on July 8, 2020. The FDA has observed that your website offers a “COVID-19 Antibody Rapid Test Kit” for sale in the United States directly to consumers for at-home use. Based on our review, this product is intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-191 in people, and thus, it is a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the “Act”), 21 U.S.C. § 321(h).

The “COVID-19 Antibody Rapid Test Kit” is 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, your product is 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). Your product is 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 device 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 this product 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 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 such unapproved, uncleared, and unauthorized product for use in 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.akivamed.com, indicates that the “COVID-19 Antibody Rapid Test Kit” may be purchased directly by consumers and is intended to be used for at-home testing for COVID-19, including:

On your website, www.akivamed.com:

  • “FDA Certified COVID-19 Rapid Test kit. This instant antibody test is simple to use. You do not need to see the doctor or even leave your house. Instructions are simple and on the package of each test. Don't pay excessive doctor or lab fees or even expose yourself unnecessarily when you can get instant results from home. This test is certified and recommended by the FDA. This kit includes everything you need to test yourself for antibodies. The tests are very simple to use.”

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. 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 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 have not been approved, cleared, or authorized by FDA and 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 corrective actions to cease the sale of your unapproved, uncleared, and unauthorized product(s) for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, 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 product is not in violation of the Act, include your reasoning and any supporting information for our consideration.

If you are not located in the United States, please note that products that appear to be adulterated or misbranded are subject to detention and refusal of admission if they are offered for importation into the United States. We may advise the appropriate regulatory officials in the country from which you operate that FDA considers your products listed above to be adulterated and misbranded products that cannot be legally sold to consumers in the United States.

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 The “COVID-19 Antibody Rapid Test Kit” offers for sale on your website appears to be the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) manufactured by Healgen Scientific LLC. On May 29, 2020, FDA issued an Emergency Use Authorization (EUA) pursuant to section 564 of the Act, 21 U.S.C. § 360bbb-3, to permit emergency use of Healgen Scientific LLC’s COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) 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 and differentiation of IgM and IgG antibodies against SARS-CoV-2 in human venous whole blood, plasma (Li+-heparin, K2-EDTA and sodium-citrate), and serum. However, this EUA does not authorize the sale of the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) manufactured by Healgen Scientific LLC 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.

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