UK-based in vitro diagnostics company EKF Diagnostics announces that the U.S. FDA has granted it 510(k) clearance for its 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 within two seconds of its whole blood-filled cuvette being inserted for analysis. This ensures immediate 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 requires minimal training. The user simply collects a capillary or venous blood sample of 10 µL in the cuvette before inserting straight into the analyzer. Also, making it suitable for POC testing use, DiaSpect Tm is factory calibrated against the HiCN reference method in accordance with the International Council for Standardization in Hematology.
Commenting, Julian Baines, CEO of EKF Diagnostics, says: “The FDA clearance of DiaSpect Tm is part of our overall strategy to widen the range of regulatory approvals for our existing product range and to drive sales growth for these products across additional geographies. The U.S. market is a key target for our DiaSpect Tm product, where we see a significant need for an easy to use, accurate and portable hemoglobin measurement system that can deliver laboratory quality results to patients in the clinic within seconds.”