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PixCell Medical Nabs FDA 510(k) for POC Direct Capillary Sampling

NEW YORK – Israeli hematology testing firm PixCell Medical said Wednesday that it secured US Food and Drug Administration 510(k) clearance for direct capillary sampling with its HemoScreen complete blood count analyzer.

The firm said the recent clearance for the HemoScreen five-part differential CBC analyzer allows sample collection directly from a patient's finger without an immediate tube, providing easier capillary blood collection that does not require a phlebotomist or physician. The analyzer had received clearance in 2018 for use with venous and capillary blood samples, and the firm said direct collection will provide advantages over other blood count devices because the method is faster, less painful, and less prone to pre-analytical errors.

PixCell said the recent clearance allows HemoScreen to reach its potential as a point-of-care analyzer that employs single-use reagent cartridges, automatic sample preparation, and a simple blood collection procedure.

"With the clearance to use direct capillary sampling, HemoScreen has become a true game changer in POC hematology, making it even easier to operate, negating pre-analytical challenges common with other CBC analyzers in the market, and increasing diagnostic throughput," PixCell Cofounder and CEO Avishay Bransky said in a statement.