Continuing a saga that goes back 20 years, FDA goes after some companies not for their in-house LDTs, but for their collection kits shipped through the mails. (See a 2013 warning letter from FDA to 23andMe disallowing a non-approved saliva collection device.) (See a 2025 warning letter from FDA to DRG instruments that a saliva collection device was sold RUO, but with text referring to its "patient samples.")
According to a new item at 360DX, the FDA recently issued warning letters to:
- Genovate
- Germaphobix
- ProDx Health
- Genetrace. Online FDA warning letter January 2026 here.
FDA's attention was especially high because direct to consumer marketing is involved. Actions could include "seizure, injunction, monetary penalties."
FDA noted that there are FDA-approved collection devices available (e.g. FDA protecting the market of companies that had invested in FDA approval.)
- Coverage at 360dx, at Medtech Insight. At PharmaTutor here.
- FDA warning letters are listed by date here.
FDA extract here:
....Based on our review, your firm has offered its HIV DBS card self-collection kit for delivery to individuals and has intended 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 any use, including 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. However, as noted above, your firm’s HIV DBS card self-collection kit has not received FDA marketing authorization for any use and to date, your firm has not submitted any premarket submission to FDA seeking authorization to market this kit.
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 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.
Actions include, but are not limited to, seizure, injunction, and civil money penalties.
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From a 2025 warning letter to DRG,
...The Salivary Cortisol ELISA RUO appears intended for clinical diagnostic use instead of for research use only. Such evidence includes:
Your firm’s website includes product descriptions, images, and statements that suggest the Salivary Cortisol ELISA RUO device is intended for clinical diagnostic use. [https://store.drg-international.com/pc_product_detail.asp?key=2EAFBB068F3341EF8772F433DA7255B4].
For example:
For example:
o A statement on your firm’s product page for the Salivary Cortisol ELISA RUO says that the “intensity of colour developed is inversely proportional to the concentration of cortisol in the patient sample.”
Labeling collected during the inspection which your firm distributes with the Salivary Cortisol ELISA RUO device includes information that appears to conflict with RUO and suggests the device is actually intended for clinical diagnostic use despite the RUO labeling. For example:
o The instructions for use that your firm distributes with the Salivary Cortisol ELISA RUO contains a specimen collection and preparation section that describes how samples should be collected from individuals (e.g. “Eating, drinking, chewing gums or brushing teeth should be avoided for 30 minutes before sampling.”) and gives directions on how saliva samples should be collected and over what time period to collect samples from individuals. The instructions for use also contain a Quality Control section which notes that “[a] statistically significant number of controls should be assayed to establish mean values and acceptable ranges to assure proper performance” and that users should ensure that assay results fit the established range of control materials or else be considered invalid. This type of language is typically included for IVDs that are intended for clinical diagnostic use, as this type of information is consistent with the prospective testing of patients and is not the type of information that is necessary for an assay in the laboratory research phase of development.
