June 2018—EKF Diagnostics announced FDA 510(k) clearance and CLIA waiver for its DiaSpect handheld hemoglobin analyzer. The POC analyzer provides users with accurate hemoglobin measurements (precision: CV ≤ one percent) within two seconds, using 10 µL of whole blood. DiaSpect is factory calibrated against the hemiglobincyanide (HiCN) reference method in accordance with the International Council for Standardization in Haematology. Recalibration and maintenance are not necessary, and the rechargeable internal battery provides up to 40 days or 10,000 tests of continuous use.
The reagent-free cuvettes have a shelf life of up to 2.5 years, even after opening, and can be stored from 0°C to 50°C; short-term storage of 24 hours is possible at -30°–70°C.
EKF Diagnostics, +44 (0) 29 20 710570