Spot On Sciences marketed its products for diagnostic testing despite telling the FDA they were intended for research use only, according to a recent warning letter.
In April 2014, the Austin, Texas, company told the FDA that its HemaSpot collection devices are for research use only and are not for use in diagnostic procedures. However, in March of that year, its website had featured a press release about partnering with another company to provide DTC diagnostic testing for various conditions, according to the April 12 letter posted online June 28. The release linked to a website where the devices could be ordered directly by consumers using an online payment service.
Further, statements on the website indicated that the dried blood spot collection devices are used in diagnostic testing. For example, the websites said the devices “greatly increase access to medical testing for chronic diseases and reduce health disparities for underserved and resource-limited populations.” It noted that “people who are home-bound or live in remote and rural areas sometimes lack transportation for routine medical screening.”
According to the site, the HemaSpot allows people to take their own blood sample with a finger stick and mail it to a testing lab.
The warning letter raps Spot On for marketing the devices without clearance or approval. During an April 2014 teleconference, CDRH gave the company three options to bring the blood collection devices into compliance: submit a 510(k) application, label the devices as research use only or label the devices for investigational use only.
Spot On told the FDA during a May 2014 conference call that it would bring its labeling into compliance by the end of May 2014 and it would remove any non-RUO claims on its website by June 11, 2015. It also pledged to create a “certification program,” requiring users to certify they would not use the device for anything other than research.
In the warning letter the FDA asks Spot On Sciences to halt any activities that result in the adulteration and misbranding of the HemaSpot Blood Collection device and HemaSpot SE device.