FDA Releases Two Final Guidance Documents on Blood Glucose Monitors
The Food and Drug Administration (FDA) has released the final versions of two guidance documents, “Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use” and “Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use.” These documents describe the studies and criteria that manufacturers should submit when seeking clearance for blood glucose monitors designed for use by healthcare professionals and patients at home, respectively.
Patients in professional healthcare settings are more likely than lay users to be acutely ill and present with physiological and pathological factors that could interfere with glucose measurements. FDA therefore recommends that for prescription use blood glucose monitors, the intended use population should be accurately defined, distinct performance parameters should be met, and sponsors should demonstrate substantial equivalence of the device for that particular use. Blood glucose monitors for home use, on the other hand, are more likely to experience varied storage and handling conditions compared to devices used in professional settings, and FDA stresses that their design should be more robust and reliable to accommodate actual use conditions. In addition, compared to professional healthcare settings, fewer controls typically exist in home use settings to mitigate the risk of erroneous results. Home blood glucose monitors should therefore be designed so the risk of an erroneous result is far less than with laboratory-based tests.
Both guidance documents also include recommendations for device design, labeling, and disinfection methods that can minimize the risk of bloodborne pathogen transmission, especially for prescription blood glucose monitors, which are more likely to be used on multiple patients. The complete versions of both guidance documents are available at www.fda.gov.
CLSI Guideline for LC-MS Methods Recognized by FDA
The Food and Drug Administration has recognized Clinical and Laboratory Standards Institute (CLSI) guideline C62-A: Liquid Chromatography-Mass Spectrometry (LC-MS) Methods, which provides guidance for the development and verification of LC-MS methods in clinical laboratories. Manufacturers can now follow the recommendations in this document when applying for 510(k) clearance or premarket approval for LC-MS–based tests. FDA has recognized the complete standard, with the exception of section 7.5.1. The recommended study designs in this section are recognized, but the agency does not recognize all listed acceptance criteria and states that, dependent on the analyte, additional studies could be required. In such a case, FDA recommends consulting with the agency’s technical contacts.
FDA Clears Siemens’ Handheld Coagulation Analyzer
Siemens Healthineers has garnered Food and Drug Administration clearance for the Xprecia Stride Coagulation Analyzer, a hand-held device that delivers prothrombin time international normalized ratio (PT/INR) testing for point-of-care monitoring and management of oral anticoagulation therapy with warfarin. The Xprecia Stride uses fresh capillary whole blood and results are expressed as INR. To minimize any potential for variability, the device also uses the same Dade Innovin reagent used by Siemens Healthineers central lab analyzers, and studies have shown the Xprecia Stride’s performance to be equivalent to a reference laboratory hemostasis system, with results available within minutes. The device also features a user interface similar to those found on smartphones, with simple icons and animation in a color display.