WARNING LETTER
USH Diagnostics, Inc./covidinstanttest.net
MARCS-CMS 612084 —
July 09, 2021
Product:
Medical Devices
Recipient:
Recipient Name
Mr. Chris Ormiston
USH Diagnostics, Inc./covidinstanttest.net
3456 E. 155th St.
Kansas City
,
MO
64147
United States
co@ushealthdiagnostics.com
cormiston@ushealthdiagnostics.com
support@covidinstanttest.net
Issuing Office:
Center for Devices and Radiological Health
United States
WARNING LETTER
Date: July 9, 2021
TO:
covidinstanttest.net
205 E. Osborn Rd.
Phoenix, AZ 85012
support@ushealthdiagnostics.com
support@americanmedicalsuppliers.com
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 https://covidinstanttest.net and https://ushealthdiagnostics.com/ on March 30, 2021, and April 9, 2021. We also reviewed your social media websites at https://facebook.com/covid19instanttest, https://twitter.com/covidathometest, and https://www.instagram.com/covid19instanttest, where you direct consumers to your website, https://covidinstanttest.net, to purchase your products. The FDA has observed that your websites https://covidinstanttest.net and https://ushealthdiagnostics.com/ offer for sale a “Rapid Dual Antibody Test” (which your website also refers to as the “COVID-19 Instant Test,” “Dual Antibody Rapid Test,” “COVID-19 Dual Antibody Test,” “Rapid 15 Minute Antibody,” “Dual IgG/IgM Screening Test for COVID-19,” “15-Minute COVID-19 Screening Test,” “COVID-19 IgM/IgG Rapid Test Device,” “COVID-19 Antibody Test Kit,” and “Dual Antibody Test”) (hereafter referred to as the “COVID-19 Antibody Test Kit”), a “Rapid 10 Minute Antigen Test” (which your website also refers to as the “Antigen Rapid Test,” “COVID-19 Antigen Test Kit,” “Access Bio COVID-19 Antigen Test,” and “COVID-19 Instant Antigen Test”) (hereafter referred to as the “COVID-19 Rapid Antigen Test”), and a “Saliva Test Kit” (all hereafter referred to as “COVID-19 Test Kits”) in the United States. Based on our review, the COVID-19 Test Kits are intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19
1
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).
The COVID-19 Test Kits are offered for sale in the United States to consumers for at-home testing without marketing approval, clearance, or authorization from FDA.
2,3
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 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.
4
In addition, on March 13, 2020, the President declared a national emergency in response to COVID-19.
5
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 products that are 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 products for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.
We also note that different and potentially serious public health risks are presented with specimen collection and testing in the home versus using a test in a healthcare setting. Risks may 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 websites, https://covidinstanttest.net and https://ushealthdiagnostics.com/, as well as social media websites, indicate that your firm’s COVID-19 Test Kits may be purchased by consumers and are intended to be used for at-home testing for COVID-19, including:
• “THE MOST RAPID COVID-19 TESTS ON THE INTERNET. PERIOD…
The Fastest Home Tests on the Market Receive Your Test Next Day, Results Available in Minutes!” [https://covidinstanttest.net/]
• “COVID-19 INSTANT ANTIGEN TEST
This diagnostic test is used to get into sporting events, board flights, and meeting other mandatory testing requirements FDA EUA AUTHORIZED LOWER NASAL COVID 10 MIN RAPID TEST Coronavirus (COVID-19) Rapid Test with Telehealth Consultation. The test is administered over a video appointment from the comfort of your home with results in 10 minutes. [https://covidinstanttest.net/antigen]
• “COVID-19 At Home Instant Test #COVID19…How does our Coronavirus (COVID-19) Rapid At Home Test work? Learn more: covidinstanttest.net
#CoronaVirus #COVID #COVID19 #SARSCoV2 #COVIDInstantTest
#COVIDRapidTest #COVIDAtHome #RapidTesting #InstantTest”
[Pinned Tweet from November 24, 2020, at https://twitter.com/covidathometest]
• “COVID-19 At Home Instant Test
Our #COVID19 Rapid Tests have received an Emergency Use Authorization from the FDA.
covidinstanttest.net”
[https://www.instagram.com/covid19instanttest/]
• “Saliva Test Kit
FDA Submitted/EUA Approved
Results in 24-48 hours
Approved for In-Home Use!
o 100% Accuracy with zero false negatives
o ZERO false positives with 100% Overall Accuracy
o Determines if the patient is currently infected.”
[https://ushealthdiagnostics.com]
• “15-Minute COVID-19 Screening Test
Self contained test can be administered at home or business under the supervision of a Telehealth professional with results in 15 minutes” [https://covidinstanttest.net/dual-antibody-test/]
Your products are also misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because your websites represent that the COVID-19 Test Kits are “FDA Submitted/EUA Approved,” “FDA EUA Authorized,” or “EUA/FDA Certified.” These representations create a false impression that your products have been approved or authorized for emergency use by FDA and are misleading. As discussed above, your COVID-19 Test Kits have not been approved or authorized for emergency use by FDA. In addition, your website, https://ushealthdiagnostics.com, displays the FDA logo positioned near images of and information about the COVID-19 Antibody Test Kit and Saliva Test Kit. The FDA logo is for the official use of the FDA and not for use on private sector materials.
6
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/coronavirus-covid-19-and-medical-devices. In addition, the guidance titled “Policy for Coronavirus Disease 2019 Tests During the Public Health Emergency (Revised)”
7
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 products 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 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 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 adequately correct any 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 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 actions to address the sale of your 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 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 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 Test Kit” offered for sale on your website appears to be the RightSign COVID-19 IgG/IgM Rapid Test Cassette manufactured by Hangzhou Biotest Biotech Co., Ltd. On December 21, 2020, FDA reissued an Emergency Use Authorization (EUA) pursuant to section 564 of the Act, 21 U.S.C. § 360bbb-3, to permit emergency use of Hangzhou Biotest Biotech Co., Ltd.’s RightSign COVID-19 IgG/IgM Rapid Test Cassette. The test is indicated for use 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 to SARS-CoV-2 in human venous whole blood (sodium heparin, potassium EDTA, and sodium citrate), serum, and plasma (sodium heparin, potassium EDTA, and sodium citrate), and, by laboratories certified under CLIA, 42 U.S.C. § 263a, to perform high, moderate, or waived complexity tests, for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in fingerstick whole blood specimens. Testing of fingerstick whole blood specimens is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.The test is intended for use as an aid in identifying individuals with an adaptive immune response toSARS-CoV-2, indicating recent or prior infection. However, this EUA does not authorize the sale of the Hangzhou Biotest Biotech Co., Ltd., RightSign COVID-19 IgG/IgM Rapid Test Cassette to consumers for at-home testing.
3
The “COVID-19 Rapid Antigen Test” offered for sale on your website appears to be the CareStart COVID-19 Antigen test manufactured by Access Bio, Inc. On April 12, 2021, FDA reissued an EUA pursuant to section 564 of the Act, 21 U.S.C. § 360bbb-3, to permit emergency use of Access Bio, Inc.’s CareStart COVID-19 Antigen test. The test is indicated for for use by laboratories certified under CLIA, 42 U.S.C. § 263a, to perform high, moderate, or waived complexity tests and in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation, for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals suspected of COVID-19 by their healthcare provider within five days of symptom onset, or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests. However, this EUA does not authorize the sale of the Access Bio, Inc. CareStart COVID-19 Antigen test to consumers for at-home testing.
4
Secretary of Health and Human Services Alex M. Azar II, 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
.
5
Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) (Mar. 13, 2020), available at
https://trumpwhitehouse.archives.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/
.
6
FDA Logo Policy (available at:
https://www.fda.gov/about-fda/website-policies/fda-logo-policy
).
7
Accessible at
https://www.fda.gov/media/135659/download
.
Content current as of:
08/10/2021
Regulated Product(s)
Medical Devices