Abbott Broadens Use Of I-STAT Handheld Blood Analyzer With CLIA Waiver Granted By FDA For CHEM8+ Test Cartridge

Main Category: Blood / Hematology
Also Included In: Medical Devices / Diagnostics;  IT / Internet / E-mail;  Regulatory Affairs / Drug Approvals
Article Date: 08 Oct 2007 - 0:00 PDT

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Abbott announced that the U.S. Food and Drug Administration (FDA) has granted waived status under the Clinical Laboratory Improvement Amendements of 1988 (CLIA) for its handheld i-STAT CHEM8+ test cartridge, making it more widely available for use beyond the hospital setting.

The waiver indicates the device is sufficiently simple and accurate and can be made more broadly available to healthcare providers where fast results are needed such as physicians' offices, emergency departments, intensive care units, operating rooms, catheterization labs, outpatient clinics and military bases. By providing these critical test results rapidly, health care providers can quickly monitor and effectively manage their patient's care.

The CHEM8+ test cartridge is the first i-STAT cartridge to receive a CLIA waiver. The cartridge is a single-use, in vitro diagnostic test cartridge for the simultaneous measurement of sodium, potassium, chloride, total carbon dioxide, glucose, urea, creatinine, ionized calcium, and hematocrit in arterial, venous, and capillary whole blood samples for the purpose of monitoring and diagnosing a patient's metabolic condition.

"Obtaining CLIA-waived status for the CHEM8+ test underscores the high quality and reliability of i-STAT cartridge technology and expands its potential beyond the hospital setting, improving the quality of care," said Greg Arnsdorff, vice president, Abbott Point of Care. "Taking advantage of i-STAT's near immediate test results, more physicians will be able to provide their patients with treatment options in one visit, eliminating the cost and hassle of a second appointment."

The i-STAT® System

The i-STAT System accelerates the availability of critical test information clinicians require to make rapid triage and treatment decisions when diagnosing a patient's condition, determining a prognosis or monitoring a patient's treatment response. Weighing only 18 ounces, the i-STAT System is an easy-to-use, hand-held analyzer capable of providing time-sensitive test results at the patient's side in just minutes. To perform a test, the user places two or three drops of whole blood on the test cartridge, which is then inserted into the analyzer. A new test cartridge is used for each patient. Utilizing test-specific cartridges that are fully self-contained, the i-STAT System delivers lab-accurate testing for blood gases, electrolytes, chemistries, coagulation, hematology, glucose and cardiac markers. i-STAT is at the forefront of expanding the possibilities with the industry's most comprehensive panel of bedside tests on a single platform. The i-STAT System is currently used in more than 1,800 hospitals, where rapid test results are critical for better patient care. The system is used in emergency departments, intensive care units, operating rooms, as well as catheterization laboratories, out-patient clinics and physician offices.

About Abbott Point of Care

Abbott Point of Care, headquartered in East Windsor, New Jersey, 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.

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 65,000 people and markets its products in more than 130 countries.

Abbott
http://www.abbott.com