Agena Bioscience, Inc. – FDA Warning Letter, Jun 13, 2023

The FDA issued a Warning Letter to Agena Bioscience, Inc. following an inspection from June 7-13, 2023. The firm manufactures the MassARRAY4 System (MA4) and iPLEX HS chemistry panels, including the iPLEX HS Colon Panel, which the FDA determined are intended for clinical diagnostic use.

The iPLEX HS Colon Panel, used with the MA4, is deemed adulterated under section 501(f)(1)(B) of the Act because the firm lacks an approved premarket approval (PMA) application or an investigational device exemption. It is also misbranded under section 502(o) for failure to notify the FDA of intent to introduce the device into commercial distribution, as required by section 510(k). Despite the firm's "For Research Use Only" (RUO) disclaimers, evidence indicates clinical diagnostic intent. The iPLEX HS Colon Panel appears to be a tumor profiling test for colorectal cancer, requiring a 510(k) or PMA submission.

Additionally, the iPLEX HS Colon Panel is misbranded under section 502(t)(2) for failing to report a correction or removal of a device initiated to reduce a health risk, as required by 21 CFR Part 806.10. Specifically, the firm did not report a June 1, 2021, customer notification regarding iPLEX