WARNING LETTER
Tresmonet Technologies, Inc., TM Testing, Inc. dba TM Technologies, Inc./TM Labs
MARCS-CMS 610158 —
March 24, 2021
Product:
Medical Devices
Recipient:
Recipient Name
Dennis Dannel
Recipient Title
Founder and CEO
Tresmonet Technologies, Inc., TM Testing, Inc. dba TM Technologies, Inc./TM Labs
424 S. Roadway
New Orleans
,
LA
70124
United States
sales@tmtestkits.com
Issuing Office:
Center for Devices and Radiological Health
United States
WARNING LETTER
Date: March 24, 2021
TO:
1001 S Broad St, Suite 126
New Orleans, LA 70135
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.tmtestkits.com on August 19, 2020 and on March 17, 2021. The FDA has observed that your website offers a “COVID-19 IgM/IgG Rapid Test” (also referred to as “COVID-19 On-Site Rapid Test,” “TM TEST KITS,” “TM Test Kits, CoVID-19 Rapid Antibody Serology Test,” “COVID-19 IgG/IgM Rapid Test Cassette,” and “2019-nCov-SARS (COVID-19) IgM/IgG Antibody Test Kit”) for sale in the United States directly to consumers for at-home testing. Based on our review, this product is intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19
1
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 IgM/IgG Rapid Test” 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.tmtestkits.com, indicates that the “COVID-19 IgM/IgG Rapid Test” may be purchased directly by consumers and is intended to be used for at-home testing for COVID-19, including:
In your product comparison table of a “PCR TEST (Nasal Swab)” versus your “TM TEST KITS”, it states that “TM TEST KITS”:
“Can Detect Antibodies…
YES
…
In-home, Self-administered Test . . .
YES
. . .
Requires Complex Lab for Results . . .
NO
. . .
Anyone Can Use and/or Read Results . . .
YES
. . .
Can Be Used Anywhere (in the field) . . .
YES
. . .” [from your website, https://tmtestkits.com]
“home-use diagnostic test designed for qualitative detection of immunoglobulin antibodies to COVID-19 virus.” [from your “TM TESTING, INC COVID-19 IgM/IgG Rapid Test ASSAY AND FACT SHEET” on your website, https://tmtestkits.com/tmrscomplience/#TMTestKitsFactSheet]
Your product is also misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because statements on your website represent that the “COVID-19 IgM/IgG Rapid Test” is “FDA-approved.”
For example:
A photograph of the “COVID-19 IgM/IgG Rapid Test” includes the following language“FDA-approved COVID-19 IgM/IgG Test Kit is a solid-phase immunochromatagraphic assay for rapid, qualitative, and differential detection of IgM and IgG antibodies to 2019-nCoV2-SARS (COVID-19) using serum, plasma, and whole blood.” [from your website, https://tmtestkits.com]
Your fact sheet entitled “TM TESTING, INC COVID-19 IgM/IgG Rapid Test ASSAY AND FACT SHEET” states that your product is“FDA APPROVED” [from your website, https://tmtestkits.com/tmrs-complience/#TMTestKitsFactSheet]
These statements create the false impression that the “COVID-19 IgM/IgG Rapid Test” has been approved by FDA and is misleading. As discussed above, the COVID-19 IgM/IgG Rapid Test” has not been 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-medicaldevices/coronavirus-covid-19-and-medical-devices
. 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 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 correct 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 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 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 product is 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
The TM Test Kits, CoVid-19 Rapid Antibody Serology Test manufactured by TM Testing, Inc. is currently listed on FDA’s “removed” serology test list, found on the FDA’s Removal Lists of Tests that Should No Longer Be Used and/or Distributed for COVID-19: FAQs on Testing for SARS-CoV-2 webpage at
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/removal-lists-tests-should-no-longer-be-used-andor-distributed-covid-19-faqs-testing-sars-cov-2
. The “removed” serology test list includes serology tests for which an Emergency Use Authorization (EUA) request was not submitted within a reasonable period of time, serology tests where significant problems are identified that cannot be or have not been addressed in a timely manner, and serology tests for which notification was voluntarily withdrawn by the commercial manufacturer. Tests on the “removed” serology test list should not be distributed in the United States unless and until an EUA is issued for the test or the test receives marketing approval or clearance from FDA.
3
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
).
4
President Donald J. Trump, Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) (Mar. 13, 2020), available at
https://www.whitehouse.gov/presidentialactions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/
).
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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