Magellan Diagnostics, Inc. FDA Warning (2017)

Detailed Analysis

False Claims and Regulatory Violations

During an inspection of Magellan Diagnostics, Inc., located in North Billerica, Massachusetts on May 10, 2017 through June 29, 2017, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures the LeadCare Blood Lead Testing System, the LeadCare II Blood Lead Testing System, the LeadCare Ultra Blood Lead Testing System, and the LeadCare Plus Blood Lead Testing System (collectively, the “LeadCare Systems”). 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.

1.    Your firm made significant labeling and design changes to the LeadCare II System after FDA’s clearance of that device on October 6, 2005. For example, the proposed labeling submitted to FDA as part of the premarket notification (510(k)) for the LeadCare II System at the time of the device’s clearance describes the readiness of the sample for analysis immediately after mixing of the treatment reagent with the blood sample. However, your firm made a significant change by adding to the device labeling an instruction that users allow the blood-treatment reagent mixture to stand for 4 hours at room temperature prior to analysis for venous blood samples that are shipped or rocked. Your firm added this 4-hour incubation time to reduce the risk of the LeadCare II System underestimating lead

2.    Your firm made significant labeling and design changes to the LeadCare Ultra System after FDA’s clearance of that device on August 20, 2013. For example, the proposed labeling submitted to FDA as part of the 510(k) for the LeadCare Ultra System at the time of the device’s clearance describes the readiness of the sample for analysis immediately after mixing of the treatment reagent with the blood sample. However, your firm made a significant change by adding to the device labeling an instruction that users implement a minimum 24-hour incubation time for the blood-treatment reagent mixture prior to analysis. Your firm made this change to reduce the risk of the LeadCare Ultra System underestimating the lead values of some blood samples. This change could significantly affect the safety

Potential Health Risks

Medical Devices and Radiological Health, Division 1 East1 Montvale AveStoneham, MA 02180

2.    Failure to ensure that design validation includes risk analysis that is complete and adequate, pursuant to 21 CFR 820.30(g). Specifically, your Risk Analysis Procedure, SOP 159, Rev 04, requires product risk analysis to be updated based on post-production information. However, your firm failed to update, identify, and/or adequately evaluate the risks to patients from falsely low results for the LeadCare Ultra, LeadCare II, and LeadCare Plus Systems. For example:

b.  The LeadCare II Risk Analysis, entitled Risk Analysis-Lead Care II, Rev 6, dated 09/08/2005, included a hazard of “Erroneous Result, False Low.” However, the analysis of this hazard was not updated based on customer complaints regarding falsely low results to reflect the likelihood of harm with respect to venous blood samples.

Regulatory Context

Our inspection revealed that your firm’s LeadCare II and LeadCare Ultra Systems are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a),(b)(4). The LeadCare II and LeadCare Ultra Systems are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce these devices into commercial distribution, in that a notice or other information respecting the modifications to each of these devices was not provided to FDA, as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3). Specifically,

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 a device is described on the Internet athttp://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.

This inspection also revealed that your firm’s LeadCare Systems are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at 21 CFR Part 820.