WARNING LETTER
Blackfly Investments, LLC dba Molecular® Testing Labs
MARCS-CMS 680324 —
October 11, 2024
Delivery Method:
VIA UPS and Electronic Mail
Reference #:
CBER 24-680324
Product:
Biologics
Recipient:
Recipient Name
Adam Blackwell
Recipient Title
Co-Founder and Head of New Product Development and Laboratory Production
Blackfly Investments, LLC dba Molecular® Testing Labs
14401 SE 1st Street
Vancouver
,
WA
98684
United States
info@moleculartestinglabs.com
adam@moleculartestinglabs.com
Issuing Office:
Center for Biologics Evaluation and Research (CBER)
United States
WARNING LETTER
Date: October 11, 2024
CBER-24-680324
Dear Mr. Blackwell:
The United States Food and Drug Administration (FDA or the Agency) has learned that your firm, Blackfly Investments, LLC dba Molecular Testing Labs (MTL), is offering for sale in the United States a human immunodeficiency virus (HIV) serological diagnostic dried blood spot (DBS) card self-collection kit (hereinafter, your “HIV DBS card self-collection kit”) without marketing authorization, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).  Under section 201(h)(1) of the FD&C Act, 21 U.S.C. 321(h)(1), your HIV DBS card self-collection kit is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.
FDA has reviewed your firm’s website, www.moleculartestinglabs.com (last reviewed October 1, 2024), your firm’s responses to previous FDA correspondence, and other information your firm has provided to the Agency.  Based on our review of these materials, your firm offers its HIV DBS card self-collection kit for delivery to individuals and intends for these individuals to use the kit to self-collect DBS samples and ship those samples to MTL for HIV testing. FDA has determined that your HIV DBS card self-collection kit is adulterated under section 501(f)(1)(B) of the FD&C Act, 21 U.S.C. 351(f)(1)(B) because it does not have an approved premarket approval application (PMA) in effect pursuant to section 515(a) of the FD&C Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the FD&C Act, 21 U.S.C. 360j(g).  Your HIV DBS card self-collection kit is also misbranded under section 502(o) the FD&C Act, 21 U.S.C. 352(o), because notification of the intent to introduce the device into commercial distribution has not been provided to the agency, as required by section 510(k) of the FD&C Act, 21 U.S.C. 360(k).
FDA has not authorized your firm’s HIV DBS card self-collection kit for any use, including for use in HIV serological diagnostic testing.
Your firm met with representatives of the FDA’s Center for Biologics Evaluation and Research (CBER) on April 7, 2022, to discuss MTL’s HIV DBS card self-collection kit.  Following that meeting, your firm represented
(b)(4)
.” In a letter dated October 28, 2022, FDA informed you that the Agency had received no such
(b)(4)
and that your HIV DBS card self-collection kit is a device under section 201(h)(1) of the FD&C Act for which FDA had no records of an approved PMA or cleared 510(k).  In subsequent correspondence to FDA dated January 13, 2023, your firm indicated that
(b)(4)
.
Your firm submitted a
(b)(4)
regarding the kit on
(b)(4)
. Subsequently, FDA provided written feedback on the questions posed in your firm’s
(b)(4)
and had a teleconference with your firm on September 28, 2023. In its feedback on the
(b)(4)
, FDA recommended that your firm submit
(b)(4)
to seek feedback on your
(b)(4)
submit a De Novo request under section 513(f)(2) of the FD&C Act to obtain marketing authorization of the HIV DBS card self-collection kit. Your firm
(b)(4)
, and FDA provided additional written feedback and held teleconferences to discuss your questions on the feedback. However, as noted above, your firm’s HIV DBS card self-collection kit has not received FDA marketing authorization for use in HIV serological diagnostic testing, and to date, MTL has not submitted a De Novo request or any other premarket submission to FDA seeking authorization to market this kit.
In a letter to your firm dated December 21, 2023, FDA explained that the Agency has not, as MTL suggested in prior correspondence, stated an intent to exercise enforcement discretion as to the statutory or regulatory requirements applicable to the HIV DBS card self-collection kit, including the requirement for premarket review.  Your firm’s response, dated January 18, 2024, indicated that
(b)(4)
. However, this response did not state that your firm will discontinue offering its HIV DBS card self-collection kit
(b)(4)
.  Your January 18, 2024 letter also stated that your firm has “made clear to its clients that the devices used for self-collected HIV testing are not authorized by the FDA for use in the home and that such uses are outside of their intended use.”  As noted above, however, FDA has not authorized MTL’s HIV DBS card self-collection kit for any intended use, including for use in HIV serological diagnostic testing.  Nevertheless, as indicated in your above referenced letters to FDA and on your firm’s website, you continue to market this device.
Your firm’s January 18, 2024 letter stated that your HIV DBS card self-collection kit
(b)(4)
.
It is critical to evaluate the safety and effectiveness of your HIV DBS card self-collection kit to understand if individuals can reliably collect their own samples and if the samples are affected by transport conditions, among other things.  In the absence of information supporting the safety and effectiveness of MTL’s HIV DBS card self-collection kit, we lack a basis to conclude that continued market access to this device is in the best interest of public health. We also note that there is an FDA-approved over-the-counter HIV test that can help meet the needs of individuals who wish to test themselves at home or who are unable to access other testing options.
The violations cited in this letter are not meant to be an all-inclusive list of violations that may exist in connection with your products.2  FDA requests that your firm cease any activities that result in the misbranding or adulteration of your HIV DBS card self-collection kit. Your firm should take prompt action to address the violations identified in this letter.  Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.
This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. If you believe that your product is not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration in your response to this letter.
Within fifteen working days of receipt of this letter, please notify FDA in writing of the specific steps that you have taken to correct any violations.  Your response should include an explanation of each step being taken to prevent the recurrence of violations as well as related documentation. If you cannot complete all corrective actions within fifteen working days, state the reason for the delay and the date by which you will complete the correction.
Your written response should be sent to the following address: U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Document Control Center, 10903 New Hampshire Avenue, WO71-G112, Silver Spring, MD 20993-0002. Please also email your response to CBERDCMRecommendations@fda.hhs.gov.
Sincerely,
/S/
Melissa J. Mendoza
Director, Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
______________________
1
(b)(4)
2
This letter focuses on your HIV DBS card self-collection kit and is not intended to be a comprehensive list of potential issues with your firm’s products.
Content current as of:
10/22/2024
Regulated Product(s)
Biologics