Healthcare Industry News:  blood analyzer 

Diagnostics FDA

 News Release - January 25, 2006

Abbott Receives FDA 510(K) Clearance for i-STAT(R) CHEM 8+ Cartridge

New Point of Care Diagnostic Test Provides Quick Assessment of Basic Metabolic Status at Patient's Bedside

EAST WINDSOR, N.J., Jan. 25 (HSMN NewsFeed) -- Abbott (NYSE: ABT ) announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its i-STATŪ CHEM 8+ cartridge, a new point of care diagnostic test used to quickly assess basic metabolic status of patients in emergency rooms, clinics, surgical suites and other critical care settings. The CHEM 8+ cartridge is designed for use with the i-STAT, a market-leading automated hand-held blood analyzer that performs a comprehensive panel of critical tests at the patient's bedside in only a few minutes, producing lab-quality results that allow health care professionals to make on-the-spot diagnosis and treatment decisions for their patients.

The new CHEM 8+ cartridge is a single-use, in vitro diagnostic test that combines a battery of basic metabolic tests -- including sodium, potassium, chloride, ionized calcium, total CO(2), glucose, blood urea nitrogen (BUN) and creatinine -- with measurements for hematocrit and hemoglobin into a single test. The i-STAT CHEM 8+ cartridge provides a rapid snapshot of the most critical homeostatic processes: glycemic control, electrolyte balance and renal function, right at the patient's side and using just a few drops of blood.

"This new test represents a significant advance in our development of a portfolio of products that address the needs of the emergency department," said Greg Arnsdorff, president, Abbott Point of Care. "By providing critical, lab-quality test results in about two minutes, the CHEM 8+ cartridge and the rest of the i-STAT menu of assays can help facilitate a clinician's ability to make quick, accurate and informed decisions at the patient's bedside."

About Abbott Point of Care

Abbott Point of Care, headquartered in East Windsor, N.J., develops, manufactures and markets critical medical diagnostic and data management products for rapid blood analysis. The company's premier product is the i-STAT, a market-leading hand-held blood analyzer capable of performing a panel of commonly ordered blood tests on two or three drops of blood at the patient's side.

Utilizing self-contained test cartridges, along with the FreeStyle Connect(TM) Precision PCx(TM) and PCx Plus(TM) glucose test strips, the i-STAT system delivers lab-accurate testing for blood gases, electrolytes, chemistries, coagulation, hematology, glucose and cardiac markers in just minutes. By providing these critical test results rapidly, health care providers can quickly monitor and effectively manage their patients' care.

The i-STAT platform is currently used in more than 1,800 hospitals today, where fast test results are critical for better patient care. The platform is used in emergency departments, critical care units, surgical suites, neonatal intensive care units and clinics.

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 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.


Source: Abbott

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