HORIBA Yumizen H2500 high-throughput hematology analyzer receives FDA 510(k) Clearance

Montpellier, France (May 29, 2024) – HORIBA has announced that its high-throughput hematology analyzer Yumizen H2500 has received 510(k) clearance from the US Food and Drug Administration (FDA), and is now available for sale in the United States.

Designed for mid-to-large-volume laboratories, the Yumizen H2500 processes 120 samples per hour offering multiple test parameters capable of alerting critical pathologies.

From a single blood sample, HORIBA Yumizen H2500 hematology analyzer reports a complete blood count (CBC) and WBC differential (DIFF) results, plus a total immaturity measurement for leukocyte count in one run, ideal for oncology pathologies. Other offerings include Nucleated Red Blood Cell count, which is platelet aggregate interference-free, three new fluorescence-free large platelet parameters, and the six controlled parameters for body fluid analysis.

The Yumizen H2500 can be applied standalone or as a fully automated modular solution HELO 2.0 by combining with a tracking system. When installed as HELO 2.0, up to six Yumizen H2500 analyzers and six slide preparation systems can be installed on one track, with over 200 preloaded rules available in the hematology expert validation station.

Yumizen H2500 has been designed to be eco-friendly and reduce environmental impact. It received the 2023 Medical Device Network Excellence Award in the Environmental category. For example, this recognized the Yumizen H2500 which requires only six reagents compared to an industry standard of 8-15. Not only reducing reagent use, but waste, toxicity, and packaging.

Arnaud Pradel, President of HORIBA ABX SAS said, “The US FDA clearance of the Yumizen H2500 is a significant milestone for HORIBA, enhancing HORIBA’s credibility and presence in the critical US healthcare sector. It signifies compliance with high safety, efficacy, and quality standards, enhancing the product's credibility globally.”

The latest research results supporting the performance of the FDA-cleared Yumizen H2500 will be presented at the 2024 ADLM Conference in Chicago July 27 – August 1.

About the product information of Yumizen H2500, please visit our website: https://horiba.link/ih1


Yumizen H2500 Hematology Analyzer-V2 logo-HORIBA Medical
Yumizen H2500 hematology analyzer