- Delivery Method:
- VIA UNITED PARCEL SERVICE
- Medical Devices
Recipient NameClinton H. Severson
Recipient TitleChief Executive Officer
- Abaxis Inc
3240 Whipple Rd
Union City, CA 94587-1217
- Issuing Office:
- Office of Medical Device and Radiological Health Operations
Division 3 West
Irvine, CA 92612
VIA UNITED PARCEL SERVICE
April 12, 2019
Clinton H. Severson, Chief Executive Officer
3240 Whipple Rd
Union City, CA 94587-1217
Dear Mr. Severson:
During an inspection of your firm located in Union City, CA from April 9 through 25, 2018, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures and distributes Class I and II in-vitro diagnostic reagents including the Piccolo Xpress chemistry analyzer and associated rotor panels/assays. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.
The Piccolo Potassium assay used with the Piccolo Xpress chemistry analyzer is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), in that it is a class III device under section 513(f), 21 U.S.C. 360c(f), and does not have an approved application for premarket approval in effect pursuant to section 515(a), 21 U.S.C. 360e(a) or an approved application for an investigational device exemption under section 520(g), 21 U.S.C. 360j(g). The device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o) in that a notice or other information respecting the modification to the device was not provided to the FDA as required by section 510(k), 21 U.S.C. 360(k), and 21 CFR 807.81(a)(3)(i). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. [21 CFR 807.81(b)] The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm
Specifically, your firm made changes that affected the potassium assay calibration specifications and ultimately changed the performance of the device, as demonstrated by customer complaints. Changes to calibration set points raise new issues of safety and effectiveness since a falsely low potassium result could lead to serious adverse consequences such as delay in treatment or no treatment for hyperkalemia; thus, this change requires a new premarket notification (510(k)). In addition, the intentional change in calibration set points is, by its nature, a change to the
performance specifications of the device that your firm did not assess whether the modifications could have significantly affected the safety or effectiveness of the device for purposes of 21 CFR 807.81(a)(3)(i) and requires a new 510(k).
We reviewed your firm’s responses dated May 14, 2018; June 15, 2018; July 20, 2018; September 7, 2018; and October 31, 2018, as well as (b)(4), concerning the Piccolo Potassium assay used with the Piccolo Xpress chemistry analyzer and conclude that a new 510(k) is required as previously stated.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed.
In addition, FDA has noted nonconformances with regards to section 501(h) of the Act (21 U.S.C. 351(h), which are deficiencies within your firm’s quality system pertaining to current good manufacturing practice requirements specified in the Quality System regulation found at 21 CFR Part 820. These nonconformities include, but are not limited to, the following:
1) Failure to establish design change procedures, as required by 21 CFR 820.30(j). For example,
A. You firm made a change to the potassium assay calibration in October 2013 without establishing pre-approved acceptance criteria or evidence of performance of risk evaluation.
We reviewed your firm’s responses dated May 14, 2018; June 15, 2018; July 20, 2018; September 7, 2018; and October 31, 2018 and conclude that they are not adequate as you did not assess whether the modifications could have significantly affected the safety or effectiveness of the device as previously stated.
Your firm’s response to this letter should be sent to: firstname.lastname@example.org. Refer to CMS case # 558421 when replying. If you have any questions about the content of this letter please contact Dr. Raymond W. Brullo, Compliance Officer at 949-608-2918 or via e-mail at email@example.com.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations and take prompt actions to correct the violations and bring the products into compliance.
Shari J. Shambaugh
Program Division Director