The FDA published a warning letter it sent to NSC Pearson over issues with the company’s Quotient ADHD being marketed as a consumer device to treat ADHD without the proper clearance.
Pearson’s system, originally named the OPTAx system, was cleared with indications for use “as a device that provides clinicians with objective measurements of hyperactivity, impulsivity and inattention to aid in the clinical assessment of ADHD,” according to the federal watchdog.
The Quotient system is a device that measures 3 indicators of ADHD, according to the company’s site, which calls it an “easy-to-administer tool” that “uses advanced motion tracking technology to track a child or adult’s micromovements while they complete a 15-20 minute computerized test.”
After examining the company’s website the FDA reported that the device is being marketed as a consumer product without proper approval. The federal watchdog said results from the device “should be interpreted only by qualified professionals.”
The agency said the company promoted that the device can “measure motion and analyze shifts in attention state, monitor response to treatment, help to optimize treatment in weeks instead of months, and help to determine the effectiveness of a new treatment or continued effectiveness of ongoing treatment when clinically indicated.”
The agency said the company had also “misbranded” the device as it introduced it for commercial distribution after making changes to its intended use without submitting pre-market notification.
The FDA requested that the company fill out the proper submission forms for approval for said clearances, or cease marketing the device outside its indications.
