Nova Biomedical, a firm out of Waltham, MA, won the first FDA clearance for a fingerstick glucose meter that can be used with critically ill patients. The clearance for the StatStrip Glucose Hospital Meter System allows arterial, venous, or capillary samples to be used from all patient types, effectively making it the only universal fingerstick glucometer on the market.
Typically plasma glucose is used as the standard in critically ill patients, but because the StatStrip Glucose corrects for abnormal hematocrit and avoids being influenced by other factors, it has shown close correlation with plasma glucose.
Some info on what led to the regulatory decision, according to Nova Biomedical:
The 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 in Rochester, MN, and Johns Hopkins Bayview Medical Center in Baltimore, MD. The submission data comprised 16,778 patients ranging from one month to 106 years old, all who were receiving intensive medical intervention/therapy in critical and intensive care settings including burn, cardiac, medical, orthopedic, neurological, and surgical.
StatStrip’s capillary results were equivalent to the arterial and venous plasma results measured on a central laboratory IDMS traceable reference method. The FDA clearance indicates that StatStrip is safe, effective, and reliable for use by CLIA-waived operators with critically ill patients.
Product page: StatStrip Glucose…
Via: Nova Biomedical…