Abbott Announces U.S. 510(k) Clearance of CELL-DYN Sapphire(TM) Hematology Instrument

ABBOTT PARK, Ill., July 25 /PRNewswire-FirstCall/ -- Abbott announced today that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its automated, high-volume hematology instrument, the CELL-DYN Sapphire(TM) -- the latest CELL-DYN hematology analyzer to incorporate monoclonal antibody tests for additional cellular analysis. A hematology instrument's primary function is to perform 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.

"Our lab evaluated numerous pediatric samples using the CELL-DYN Sapphire. The instrument's fluorescent technology offers many unique utilities for patient sample analysis, including the ability to add monoclonal applications and potentially incorporate additional assays that may be used to better diagnose infection," said Mark Steele, M.D., hematology laboratory director, Children's Hospital Medical Center, Akron, Ohio.

CELL-DYN Sapphire's blue diode laser offers fluorescence and patented Multi-Angle Polarized Scatter Separation (M.A.P.S.S.(TM)) technology to provide advanced analysis of red blood cells, white blood cells and platelets. This information, in turn, helps physicians diagnose and monitor anemia, cancers and infectious diseases.

With its monoclonal antibody tests, CELL-DYN Sapphire also provides common flow cytometry capabilities, allowing some tests to be performed in the hematology laboratory versus being sent out to a specialized lab for processing. For example, one test can provide T-lymphocyte subset identification used in monitoring patients with HIV while another monoclonal test allows the instrument to perform a highly accurate immunological platelet count to help make decisions regarding platelet transfusions.

"The CELL-DYN Sapphire has been designed to help high-volume laboratories address their most critical and complex patient samples," said Harold Flynn, divisional vice president and general manager, Abbott Hematology. "Building on Abbott's sophisticated technology, CELL-DYN Sapphire further automates testing, providing laboratories with higher first pass, reportable results to assist in patient care and improve laboratory efficiency."

Abbott's full line of automated hematology instruments includes the CELL-DYN(R) 3700, CELL-DYN(R) 3200, CELL-DYN(R)1800 and CELL-DYN(R) SMS(TM) [Slide Maker Stainer]. Additionally, earlier this year, Abbott announced an agreement for two, 5-part differential hematology instruments to be distributed, following clinical studies and regulatory clearance, under the CELL-DYN Pearl(TM) brand name.

About CELL-DYN

Abbott's CELL-DYN family of hematology instruments is 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.

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 more than 60,000 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/ .