4U Health Warning Letter for Unauthorised HIV DBS Card Self-Collection Kit
Summary
FDA issued a Warning Letter to 4U Health (Hilton Head Island, SC) on March 17, 2026, for selling an HIV serological diagnostic dried blood spot (DBS) card self-collection kit without marketing authorisation. CBER determined the kit is a device under section 201(h)(1) of the FD&C Act, adulterated under section 501(f)(1)(B) due to lacking an approved PMA or IDE, and misbranded under section 502(o) for failing to provide 510(k) notification. FDA rejected the firm's argument that it merely facilitates access to professional medical services, stating the collection kit itself is a device regardless of physician involvement. The firm must respond within fifteen working days with specific corrective steps.
Diagnostics companies offering or facilitating at-home self-collection kits intended for disease diagnosis should audit their regulatory status: FDA treats the collection kit itself as a device requiring either 510(k) clearance, PMA approval, or IDE authorisation before commercialisation, regardless of whether a physician orders or interprets the test. Firms that rely on a 'facilitation' or 'service' framing while shipping collection materials to consumers should treat this letter as a clear signal that FDA rejects that characterisation.
About this source
FDA Warning Letters are public notifications to firms the agency believes are significantly violating FDA regulations. Common triggers include Current Good Manufacturing Practice violations, unauthorized drug claims, substandard clinical trial conduct, unapproved marketing, and tobacco sales to minors. Letters require a written response within 15 working days. Around 75 letters land each month across drug manufacturers, medical device makers, tobacco retailers, and dietary supplement companies. Watch this if you run a regulated manufacturing operation, advise on FDA compliance, defend companies in enforcement matters, or track quality-system failures that precede recall events. GovPing publishes each letter with the recipient, agency division, and cited violations.
What changed
FDA's Center for Biologics Evaluation and Research (CBER) issued a Warning Letter to 4U Health finding that its HIV serological diagnostic DBS card self-collection kit is an adulterated device under section 501(f)(1)(B) of the FD&C Act (lacking approved PMA or IDE) and a misbranded device under section 502(o) (lacking required 510(k) notification). The agency rejected the firm's argument that it does not sell testing kits but merely facilitates access to medical services, stating the kit itself is a device regardless of physician involvement in ordering or interpreting tests. The letter identifies safety concerns with self-collection including proper specimen collection, shipping stability, and adequate sample integrity given shipping conditions. Failure to adequately address violations may result in seizure, injunction, and civil money penalties without further notice.
Any firm offering self-collection diagnostic kits for home use that are intended for disease diagnosis must obtain FDA marketing authorisation before commercialisation. The involvement of physician consultants or labelling the service as a referral does not exempt a kit from device regulation. Companies should review their product portfolios to confirm that home-collection diagnostic products have received appropriate FDA clearance or approval, and should not rely on arguments that physician involvement transforms a device into a non-device service.
What to do next
- Cease any activities that result in the misbranding or adulteration of your HIV DBS card self-collection kit.
- Within fifteen working days of receipt of this letter, notify FDA in writing of the specific steps that you have taken to correct any violations.
- 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.
Archived snapshot
Mar 25, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Delivery Method: Via UPS and EMAIL Reference #: CBER 26-720527 Product: Biologics Recipient: Recipient Name Alfred Caminos Recipient Title Co-Founder and Managing Director 4U Health 71 Lighthouse Road, Suite 220
Hilton Head Island, SC 29928
United States
help@4uhealth.com Issuing Office: Center for Biologics Evaluation and Research (CBER) United States
WARNING LETTER
March 17, 2026
CBER 26-720527
Dear Alfred Caminos:
The United States Food and Drug Administration (FDA or the Agency) has learned that your firm, 4U Health, 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 company’s website at www.4uhealth.com (last visited March 2026) and your firm’s responses to previous FDA correspondence. 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 laboratories 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 use in HIV serological diagnostic testing.
In a letter dated March 31, 2025, FDA informed you that you appeared to be offering for sale and distributing your HIV serological diagnostic self-collection kits in a manner that may violate the FD&C Act. In your response dated April 30, 2025, you assert that 4U Health “do[es] not sell self-collection testing kits,” and that 4U Health instead “facilitates access to professional medical services, including HIV testing.” You indicate that “[y]our physician consultants order” tests and “oversee the entire testing process.” And you state that the “service” you offer is “not intended to diagnose, treat, or cure any disease on its own,” as “[p]ositive results require confirmation and diagnosis by a licensed medical provider not affiliated with 4U Health.”
Express statements on your firm’s website and in your April 30, 2025 response make clear that your firm is selling and distributing HIV serological diagnostic self-collection kits. For example, your website states that the kit “will arrive in plain packaging” and “contains everything you need to collect your home sample.” And your April 30, 2025 response acknowledges that your “at-home testing collection supplies” are “provided to [y]our clients for sample collection.” As explained above, because your firm’s HIV DBS card self-collection kit is a device that has not received FDA marketing authorization, the kit is adulterated and misbranded.
Notably, this letter and the March 31, 2025 letter sent to your firm focus on your HIV serological diagnostic self-collection kits and are not intended to be a comprehensive list of potential issues with your firm’s products. Even if, as you say, any testing you conduct on samples is intended to provide only preliminary results, the kits you “source[] from independent distributors” and ship to customers for the purpose of sample collection by customers “at-home” (as stated in your April 30, 2025 response) are devices. Nor does the involvement of “physician consultants” in ordering any testing or interpreting any results mean that the collection kits you are shipping are not devices.
Without appropriate testing, data review, and marketing authorization, there is a lack of assurance of the safety and effectiveness of your HIV DBS card self-collection kit. Self-collection raises several issues of importance, including, for example, whether the user can safely and properly collect the specimen, if the sample has been properly shipped, and if there is adequate stability of the specimen given the time lapse between collection and testing and the potential impact of shipping conditions. We also note that there are FDA-approved over-the-counter HIV tests 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. FDA requests that your firm immediately 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 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.
Send your electronic response and any questions regarding this letter to CBER’s Office of Compliance and Biologics Quality, Division of Case Management at CBERDCMRecommendations@fda.hhs.gov.
Sincerely,
/S/
Melissa J. Mendoza
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
- ## Content current as of:
03/24/2026
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