Subjects: PDT, FDA
HemoCue Announces FDA 510(k) Clearance and U.S. Launch of Its Latest Point-of-Care Hemoglobin Test, the HemoCue® Hb 801 System
BREA, Calif., Feb. 20, 2019 /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
About 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.
1 K181751; FDA cleared on February 1, 2019
*Consult individual state and/or organization regulations
SOURCE HemoCue America
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