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FDA clearance given for haemoglobin analyser

14th May 2018


EKF Diagnostics has announces U.S. Food and Drug Administration (FDA) 510(k) clearance and CLIA waiver for its handheld, reagent-free haemoglobin analyser, the DiaSpect. The device is cleared for use in point of care (POC) and Certificate of Waiver settings, such as doctors' offices, clinics and other non-traditional laboratory locations.
 
The DiaSpect provides users with accurate hemoglobin measurements (precision: CV ¾1%) within two seconds of its whole blood-filled cuvette being inserted for analysis. This ensures immediate and robust haemoglobin results for patient health checks and anemia screening at the point of care.
 
Based on its FDA categorisation, system 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 in the cuvette before inserting straight into the analyser. Also making it simple for POCT use, the product is factory calibrated against the HiCN reference method in accordance with ICSH. It is Œalways on and ready to use with no re-calibration or maintenance necessary.
 





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