Sysmex America Receives FDA Clearance for Automated CBC Analyzer

pocH-100i Introduced as a Hematology Solution for the Low Volume Clinical Setting

01-Mar-2004

Sysmex America, Inc. announced that the Sysmex pocH-100i(TM), a compact complete blood count (CBC) and 3-part differential hematology analyzer, has been cleared by the United States food and Drug Administration.

The Sysmex pocH-100i (TM) Automated Hematology Analyzer is to be marketed to the clinical laboratory as well as to the physician office market. The instrument reports a CBC with 3-part differential. It has the smallest footprint and smallest sample requirement of any hematology analyzer released by Sysmex. Sampling is done in a "closed tube" environment to assure safety for the operator.

The pocH-100i provides comparable results to the Sysmex hematology high- end systems, which is beneficial when the analyzer is used in an integrated health network (IHN). The technology of the system 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 non-hazardous reagent systems.

With the Sysmex pocH-100i, the physician -- whether in the office or at the hospital -- has immediate access to important diagnostic information for her patient. 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 POL 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," said Kazuya Obe, President & CEO of Sysmex America, Inc.

https://www.bionity.com/en/news/35818/sysmex-america-receives-fda-clearance-for-automated-cbc-analyzer.html