FDA WARNING_LETTER - Abaxis Inc - April 25, 2018

An FDA inspection of Abaxis, Inc. in Union City, CA, from April 9-25, 2018, revealed significant violations concerning their Piccolo Xpress chemistry analyzer and associated Piccolo Potassium assay. The FDA determined the Piccolo Potassium assay is adulterated as a Class III device lacking an approved premarket approval (PMA) or investigational device exemption (IDE) application, as per sections 501(f)(1)(B), 513(f), 515(a), and 520(g) of the Act. Furthermore, the device is misbranded under section 502(o) because modifications, specifically changes to potassium assay calibration specifications that affected device performance and raised new safety/effectiveness issues (e.g., falsely low potassium results), were not submitted to the FDA via a 510(k) notification as required by 21 CFR 807.81(a)(3)(i). The firm also demonstrated deficiencies in its quality system, including a failure to establish design change procedures as required by 21 CFR 820.30(j). This was evidenced by an October 2013 change to the potassium assay calibration without pre-approved acceptance criteria or risk evaluation. Abaxis, Inc. must notify the FDA within fifteen business days of the specific corrective actions taken, including documentation and a timetable for implementation, to address these violations and prevent recurrence. The FDA emphasized that this letter is not an exhaustive list of violations, and the firm is responsible for ensuring full compliance with all applicable regulations.