HemoCue Announces FDA 510(k) Clearance and U.S. Launch of Its Latest Point-of-Care Hemoglobin Test, the HemoCue® Hb 801 System

Point-of-Care Device Seamlessly Fits Into Clinic Workflow, Increasing Access to Important Test

BREA, Calif./PRNewswire/ -- HemoCue, the pioneer and global leader of point-of-care hemoglobin (Hb) testing (with HemoCue AB global headquarters in Ängelholm, Sweden), announced it received Food and Drug Administration (FDA) 510(k) clearance1 of the HemoCue® Hb 801 System, its newest test that enables healthcare providers to assess patients' hemoglobin levels while present in their clinics.  Subsequently, HemoCue has announced immediate commercial availability of the HemoCue® Hb 801 System to physician lab offices across the United States.

"HemoCue is a pioneer in point-of-care testing," said Christophe Duret, president of HemoCue AB. "Our tests make it easy for clinicians to get a lab-quality result while the patient is present, which allows for more engagement in the overall healthcare process."

Hemoglobin testing helps clinicians to detect anemia, a condition in which the body lacks enough healthy red blood cells, or hemoglobin.  Anemia, in most cases, is very treatable. 

The HemoCue® Hb 801 System quantitatively measures hemoglobin in capillary or venous whole blood, and is for professional in vitro diagnostic use only.  The HemoCue® Hb 801 System is intended to be used to determine the hemoglobin concentration for adults, adolescents, children, and infants above 1 month old.  The HemoCue® Hb 801 System consists of an analyzer together with microcuvettes, and is CLIA-waived.  The HemoCue® Hb 801 System seamlessly integrates into your daily clinic operation with such advancements as:

  • Large display with intuitive on-screen symbols
  • Results in under one second
  • Internal quality control self-test*
  • Reagent-free cuvettes, improving open-vial stability
  • Bluetooth wireless capability
  • No preventative maintenance

"With more than 35 years in point-of-care testing, we understand the everyday challenges to ensure a smooth-running clinic as critical to patient care," said Chris Mueller, interim general manager of HemoCue America.  "The advancements of our HemoCue® Hb 801 System, combined with our comprehensive service offering, enable point-of-care hemoglobin testing to fit seamlessly into a clinic's daily workflow." 

HemoCue owns and operates all aspects of a customer's experience, providing direct support from one source. This level of support provides a best-in-class comprehensive offering, including:

  • Extensive in-field support from a HemoCue representative
  • Complementary, comprehensive on-site or online product training programs
  • Live customer service and technical support when you need it

1 K181751; FDA cleared on February 1, 2019

*Consult individual state and/or organization regulations

Nice Insight

Nice Insight, established in 2010, is the research division of That’s Nice, A Science Agency, providing data and analysis from proprietary annual surveys, custom primary qualitative and quantitative research as well as extensive secondary research. Current annual surveys include The Nice Insight Contract Development & Manufacturing (CDMO/CMO), Survey The Nice Insight Contract Research - Preclinical and Clinical (CRO) Survey, The Nice Insight Pharmaceutical Equipment Survey, and The Nice Insight Pharmaceutical Excipients Survey.

HemoCue

HemoCue is a global leader in point-of-care hemoglobin testing. In 1982, HemoCue AB, based in Ängelholm, Sweden, introduced the first system making accurate hemoglobin testing possible in near-patient settings. Since then, more than 400,000 HemoCue systems have been sold worldwide. The company also offers point-of-care tests for glucose, urine albumin, HbA1c, total and differential white blood cell count. HemoCue subsidiaries, franchises, and third-party distributors supply HemoCue products in more than 130 countries worldwide. HemoCue has been part of the Danaher Corporation's diagnostic platform since April 2013.

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