FDA WARNING_LETTER - Pinnacle Labs of Tennessee, LLC - November 03, 2023

The FDA issued a Warning Letter to Pinnacle Labs of Tennessee, LLC dba Pinnacle BioLabs following an inspection from October 27 to November 3, 2023. The firm markets the "Second Generation FIT Fecal Immunochemical Test," which the FDA determined is an unapproved and misbranded device.

The device is marketed for colorectal cancer screening, a new intended use significantly different from its previously cleared predicate device, the (b)(4) Fecal Occult Blood (FOB) (b)(4), which was cleared only for detecting fecal occult blood as an aid in diagnosing gastrointestinal disorders. Pinnacle BioLabs repackaged and relabeled the cleared device, replacing the original manufacturer's insert with their own labeling claiming colorectal cancer screening. This new intended use classifies the device as a Class III device requiring premarket approval (PMA), which the firm lacks. The device is adulterated under section 501(f)(1)(B) of the Act and misbranded under section 502(o) for failure to submit a 510(k) notification or have an approved PMA.

Furthermore, the inspection revealed Quality System regulation violations, including failure to establish and maintain procedures for complaint handling (21 CFR 820.198(a)), corrective and preventive action (CAPA) (21 CFR 820.100(a)), and design controls (21 CFR 820