Abbott Receives FDA Clearance For New CELL-DYN(R) Emerald(TM) Hematology Instrument

Main Category: Blood / Hematology
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 12 Feb 2009 - 2:00 PDT

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Abbott (NYSE: ABT) announced it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new, compact hematology instrument, CELL-DYN Emerald(TM). Abbott's CELL-DYN Emerald will expand the company's hematology platform by offering a high performance, affordable solution for small to mid- sized clinical laboratories.

As small to mid-sized hospital laboratories and clinics continue to seek greater efficiency and productivity under tighter space limitations, Emerald's small size, touch screen software, and reliability offer an easy-to-use, compact table/bench top instrument for performing complete blood counts (CBCs), a test routinely ordered by doctors to assess a patient's overall health and to screen for a variety of disorders such as anemia and infection.

This new hematology system has many automation features designed to save laboratories' time, allowing them to improve productivity and reduce costs. Time saving features of Abbott's CELL-DYN Emerald include:

-- A full touch-screen monitor to simplify operation.

-- One-button startup.

-- Low reagent consumption.

-- Automatic cleaning and shutdown features.

-- Barcode labeled reagents.

A key facet of CELL-DYN Emerald is its compact size -- weighing just 9kg (< 20 lbs) -- as well as its intuitive software interface that allows for easy navigation and quick results. With Abbott's Emerald, CBC results are completed in 60 seconds and reported in an easy-to-read format with histograms representing white blood cells, red blood cells and platelets.

"As hospitals and clinics try to do more, faster and in less space, Abbott's CELL-DYN Emerald offers a compact, fast, reliable analyzer to support the hematology testing needs of many small to medium-sized hospital laboratories and clinics," said Mike Warmuth, senior vice president, diagnostics, Abbott.

About CELL-DYN

Abbott's CELL-DYN Emerald joins the company's full line of automated hematology instruments including: CELL-DYN Sapphire(R), CELL-DYN Ruby(R), CELL-DYN(R) 3700, CELL-DYN(R) 3200 and CELL-DYN(R) 1800.

Abbott's CELL-DYN instruments are well known for their efficiency and ability to provide fast access to patient results. Instruments range from larger analyzers that process a high number of patient samples to smaller instruments designed for medium and small-volume facilities.

Besides supplying standard CBC results, some instruments have additional features to aid in the evaluation of more complex disease states or infections including cancer, HIV and a variety of anemias.

About Abbott's Diagnostics Businesses

Abbott is a global leader in in vitro diagnostics and offers a broad range of innovative instrument systems and tests for hospitals, reference labs, molecular labs, blood banks, physician offices and clinics. With more than 65,000 institutional customers in more than 100 countries, Abbott's diagnostic products offer customers automation, convenience, bedside testing, cost effectiveness and flexibility. Abbott has helped transform the practice of medical diagnosis from an art to a science through the company's commitment to improving patient care and lowering costs. The history of Abbott is filled with examples of first-of-a-kind diagnostic products and significant technological and research advancements.

About Abbott

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs approximately 69,000 people and markets its products in more than 130 countries.

Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com.

Abbott
http://www.abbott.com

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