WARNING LETTER
CoreMedica Laboratories, Inc.
MARCS-CMS 608757 —
July 24, 2020
Product:
Medical Devices
Recipient:
Recipient Name
Cory Zuehlsdorf
Recipient Title
COO & Director North America
CoreMedica Laboratories, Inc.
200 NE Missouri Road, Ste 304
Lees Summit
,
MO
64086
United States
info@coremedicalabs.com
info@testmydrop.com
Issuing Office:
Center for Devices and Radiological Health
United States
WARNING LETTER
Date:   July 24, 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 websites at the Internet addresses www.coremedicalabs.com and www.testmydrop.com on June 18, 2020. FDA has observed that your websites offered an at-home sample collection kit that instructed individuals to send a blood sample to you for COVID-19
[1]
serology testing, specifically the “COVID-19 (SARS-CoV-2) ANTIBODY SCREENING KIT Specimen Self-Collection & Transport Kit” (also referred to as the “Drop™ Convenient Self-Collection Screening Kit, “Drop™ COVID-19 antibody test”, and  “COVID-19 Screening Test”). Based on our review, the “COVID-19 (SARS-CoV-2) ANTIBODY SCREENING KIT Specimen Self-Collection & Transport Kit” is intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19 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 (SARS-CoV-2) ANTIBODY SCREENING KIT Specimen Self-Collection & Transport Kit” was offered for sale and distributed in the United States without marketing approval, clearance, or authorization from FDA. 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.
[2]
In addition, on March 13, 2020, the President declared 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 below, you offered for sale 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 corrective action to prevent the sale of such unapproved, uncleared, and unauthorized products for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.
Different and potentially serious public health risks are presented with sample collection in the home versus a healthcare setting.
Such risks may include, but are not limited to,
whether a lay user can safely and properly collect the specimen; whether the components of the specimen transport media are safe for use in the home environment; adequate stability of the specimen given the time lapse between collection and testing; proper shipment; and the potential impact of shipping conditions on the sample. Your websites indicate that your product is intended to be used for at-home blood sample collection for COVID-19 serology testing, including:
“COVID-19 (SARS-CoV-2) ANTIBODY SCREENING KIT
SPECIMEN SELF-COLLECTION & TRANSPORT KIT” [www.testmydrop.com; www.coremedicalabs.com]
“Key Benefits
Easy Self-Collection of your blood sample.
Reduces risk of exposure to yourself and others, use in the privacy of your own home…
Protection to our first responders. (Eliminates PPE changes)…” [www.testmydrop.com
;
www.coremedicalabs.com]
“How to purchase COVID-19 Screening Test
For Health Care Professional / Bulk Order – Please contact us.
For Single / Personal Use – BUY COVID KIT NOW [when clicked, links to www.testmydrop.com]” [www.coremedicalabs.com]
The “COVID-19 Antibody Screening Test General Information” document found under the heading “COVID-19 Screening Test Supporting Documents” displays four images to demonstrate “Blood Spot Collection.” The first image displays what appears to be an individual self-collecting a blood sample with the instruction, “Lance Side of Fingertip.” The other instructions state: “Apply 4 Drops. Wait 3 Minutes. Close & Ship.” [www.coremedicalabs.com]
“COVID-19 Antibody Test Kit
Our drop™ self-collection kit contains all necessary supplies for the self-collection of one capillary blood specimen and transport system to CoreMedica Laboratories for COVID-19 Antibody serology analysis“ [
www.testmydrop.com
]
“WHY drop™ COVID-19 ANTIBODY SCREENING TEST
…drop™ is an easy-to-use, capillary blood self-collection and transport kit for professional analysis of SARS-CoV-2 virus IgG and IgM antibodies. The capillary specimen can be collected any time and practically anywhere and with no additional requirements, as it does NOT require professional collection or self-collection under the supervision of a healthcare professional.” [
www.testmydrop.com
]
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)”
[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 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 prevent future violations
.
Include an explanation of each step being taken to prevent the recurrence of 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 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 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.
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 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, and July 23, 2020. Secretary of Health and Human Services Alex M. Azar II, Renewal of Determination that a Public Health Emergency Exists. (Accessible at https://www.phe.gov/emergency/news/healthactions/phe/Pages/covid19-21apr2020.aspx; https://www.phe.gov/emergency/news/healthactions/phe/Pages/covid19-23June2020.aspx).
[3]
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/).
[4]
Accessible
at https://www.fda.gov/media/135659/download.
Content current as of:
08/12/2020
Regulated Product(s)
Medical Devices