NEW YORK (360Dx) – EKF Diagnostics Holdings said today that the US Food and Drug Administration has granted 510(k) clearance and a CLIA waiver for use of its hand-held reagent-free hemoglobin analyzer, the DiaSpect Tm, in point-of-care settings.
The test provides users with accurate hemoglobin measurements within two seconds of the microcuvette being placed into the analyzer, EKF said, adding that the analyzer is palm-sized, easy to transport, and battery operated for remote use.
Julian Baines, CEO of EKF, said in a statement that the FDA-cleared hemoglobin analyzer is part of the firm's overall strategy to broaden regulatory approvals for its existing range of products "and to drive sales growth for these products across additional geographies."
He said that in the US, a key location for targeting sales of the analyzer, the firm sees "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."
According to the EKF website, the analyzer uses a broad-spectrum photometric method for detection, and it has received CE marking.