US FDA clearance for Diaspect Tm hemoglobin analyzer
EKF Diagnostics announces US Food and Drug Administration 510(k) clearance and CLIA waiver by statute for the Company’s hand-held reagent-free hemoglobin analyzer, the DiaSpect Tm, approving the product for use in point of care and Certificate of Waiver settings.
The DiaSpect Tm provides users with accurate hemoglobin measurements within two seconds of the microcuvette being placed into the analyzer. It is palm-sized, easy to transport and is battery operated for remote use.
Commenting, Julian Baines, CEO of EKF, said:
“The FDA approval 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 US 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.”