EKF secures FDA clearance for POC hemoglobin analyzerDiaSpect Tm - Easy to use, reagent-free analyzer for use in POC & CLIA waived settings
EKF Diagnostics, the global in vitro diagnostics company, announces U.S. Food and Drug Administration (FDA) 510(k) clearance and CLIA waiver for the Company’s hand-held, reagent-free hemoglobin analyzer, the DiaSpect Tm. The device is cleared for use in point of care (POC) and Certificate of Waiver settings, such as physicians’ offices, clinics and other non-traditional laboratory locations.
The DiaSpect Tm provides users with accurate hemoglobin measurements (precision: CV ≤1%) within two seconds of its whole blood-filled cuvette being inserted for analysis. This ensures immediate and robust hemoglobin results for patient health checks and anemia screening at the point of care.
Based on its FDA categorization, DiaSpect Tm can be used in a variety of settings, as well as by a wide range of health care personnel. Essential for this, it is highly user-friendly requiring minimal training. The user simply collects a capillary or venous blood sample of 10 µL