The Sysmex pocH-100i™, a compact complete blood count (CBC) and three-part differential hematology analyzer, has been cleared by the US Food and Drug Administration (FDA). The new analyzer will be marketed to the clinical laboratory and the physician office markets. It has the smallest footprint and smallest sample requirement of any Sysmex hematology analyzer. Sampling is done in a closed-tube environment for operator safety.
     The pocH-100i provides comparable results to high-end Sysmex hematology systems and the technology is common to other Sysmex systems. The red cells and platelets are measured utilizing the same hydrodynamic sheath flow technology as Sysmex’s high-end systems. The differential provides a true neutrophil count, which is important for diagnosis and ongoing monitoring of patient therapy. As with all Sysmex analyzers, the system utilizes only nonhazardous reagent systems.
     According to Charles Dahlgren, general lab manager at St. John’s Regional Health Care in Springfield, Mo and an evaluator for the FDA study, “The Sysmex pocH-100i is a reliable and easy-to-operate system that has application for use in the satellite lab, clinic, or physician office lab setting.”
     “The FDA’s clearance of the pocH-100i automated hematology analyzer paves the way for our company to enter the physician marketplace with a product that has application for the more than 13,000 physician office labs performing non-CLIA waived CBC testing as part of patient care,” says Kazuya Obe, president and CEO of Sysmex America Inc.
Sysmex America Inc
(800) 379-7639; www.sysmex.com