Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/kbmo-diagnostics-llc-607822-06172020
Timestamp: 2020-08-10 20:22:45
Document Index: 672052338

Matched Legal Cases: ['§ 321', '§ 351', '§ 360', '§ 360', '§ 352', '§ 360', '§ 331', '§ 331']

KBMO Diagnostics, LLC - 607822 - 06/17/2020 | FDA
KBMO Diagnostics, LLC - 607822 - 06/17/2020
KBMO Diagnostics, LLC MARCS-CMS 607822 — June 17, 2020
This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address www.kbmodiagnostics.com on June 16, 2020. FDA has observed that your website offers an at-home sample collection kit that can be sent to your firm for COVID-191 serology testing, specifically the “COVID-19 Fingerstick Test Kit.” Based on our review, this product 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 Fingerstick Test Kit” is offered for sale and distributed in the United States for at-home use 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.
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 website, www.kbmodiagnostics.com, states that your product is intended to be used for at-home blood sample collection for COVID-19 serology testing, including the following:
o Your website includes the following in its FAQs: “When will at home blood spot test be available? The Blood Spot (fingerstick) test has been released. Doctors can order the test and we will send a fingerstick test to the home of the patient who will UPS the dry blood spot card to the KBMO laboratory.”
o Your website includes a video titled, “BloodSpot Collection Tutorial Video,” demonstrating how to self-collect a blood sample at home and providing directions for mailing a sample collected at home to your firm.
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/presidentialactions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/).