FDA has recently cleared the StatStrip glucose hospital meter by Nova Biomedical, Waltham, Mass, for fingerstick capillary testing with critically ill patients. StatStrip is the only glucose meter to earn this clearance and can now be used with arterial, venous, or capillary specimens from all patients, including the critically ill.
FDA granted 510(k) clearance to StatStrip for capillary testing with critically ill patients following extensive prospective and retrospective studies performed at the Mayo Clinic and at Johns Hopkins Bayview Medical Center. The submission data comprised 16,778 patients ranging from 1 month to 106 years of age, all of whom were receiving intensive medical intervention or therapy in critical and intensive care settings, including burn, cardiac, medical, orthopedic, neurological, and surgical departments.
StatStrip’s capillary results were equivalent to the arterial and venous plasma results measured via a central laboratory method traceable to an isotope dilution mass spectrometry (IDMS) reference method. The FDA clearance indicates that StatStrip is safe, effective, and reliable for use by CLIA-waived operators with critically ill patients.
StatStrip’s glucose technology is the primary reason for the clinically acceptable agreement between the capillary and plasma glucose results. StatStrip uses the only glucose measuring technology for point-of-care testing that measures and corrects for abnormal hematocrit and has no clinically significant interferences, which can lead to the mismanagement of critically ill patients.
Capillary specimens are easy to collect and are the least-invasive specimens for glucose testing at the point of care. Capillary specimens provide benefits such as rapid and actionable glucose results for immediate glycemic assessment and intervention, saving time for healthcare providers and improving safety and outcomes for patients. StatStrip’s new capillary clearance eliminates the need for hospitals using StatStrip to define when a patient is considered ‘critically ill.’
In 2014, based on the results of a 4-year, multicenter prospective study conducted at five university medical centers, StatStrip became the only glucose meter to receive FDA clearance for arterial, venous, neonatal arterial, and neonatal heelstick use in all hospital and professional healthcare settings, including with critically ill patients. In that study, StatStrip’s whole blood glucose measurements of 1,698 critically ill patients spanning 257 different medical conditions and more than 8,000 medications were found to be equivalent to plasma glucose central laboratory IDMS-traceable methods.
For further information, visit Nova Biomedical.