- Medical Devices
- Issuing Office:
- Center for Devices and Radiological Health
Date: February 17, 2022
TO: 7220 Trade St. Suite 338
San Diego, CA 92121
RE: Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations, Lusys Laboratories, Inc., located at 6620 Mesa Ridge Road, Suite 100, San Diego, CA from September 13 through September 24, 2021. During this inspection, FDA investigators determined that your firm is a medical device manufacturer of the COVID-19 IgG/IgM Antibody Test and a COVID-19 Viral Antigen Test (both hereinafter collectively referred to as “COVID-19 Test Kits”) in the United States. Based on our review, your COVID-19 Test Kits are intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-191 in people, and thus, they are devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the “Act”), 21 U.S.C. § 321(h).
Our inspection revealed that your COVID-19 Test Kits have been distributed in the United States without marketing approval, clearance, or authorization from FDA. Accordingly, your 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). 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 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 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 herein, you have distributed products that are intended for use in mitigation, prevention, treatment, diagnosis, or cure COVID-19 in people. We request that you take immediate corrective action to prevent the distribution of any unapproved, uncleared, and unauthorized products for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.
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)4” 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 prevent future violations. This letter is not meant to be an all-inclusive list of violations that exist in connection with your products or operations. It is your responsibility to ensure that the products you distribute 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 misleadingly representing your products 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 products in violation of the Act. Within 48 hours, please send emails to COVID-19-Task-Force-CDRH@fda.hhs.gov describing the specific steps you have taken to prevent future 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 prevent future violations 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 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 prevent the distribution of unapproved, uncleared, and unauthorized products 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.
Timothy T. Stenzel, M.D., Ph.D.
OHT7: Office of In Vitro Diagnostics and
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-declaringnational-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.
4 Accessible at https://www fda.gov/media/135659/download.