Abbott Receives FDA CLIA Waiver For Use Of Five Additional Cartridges On The I-STAT Handheld Blood Analyzer

Main Category: Blood / Hematology
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 20 Jan 2009 - 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 Amendments of 1988 (CLIA) for five additional test cartridges used by its i-STAT handheld blood analyzer.

Cartridges for E3+, EC4+ and 6+ aid the clinician in assessing a patient's metabolic state within a few minutes. The glucose cartridge quickly delivers a patient's diagnostic blood glucose level. Creatinine is a measure and indicator of a patient's renal function right at the patient's side. The five are components of the CHEM8+ cartridge, which the FDA waived in 2007. The CHEM8+ cartridge allows a clinician to run a basic chemistry panel on a patient together with hemoglobin and hematocrit tests. Waived status makes these tests more widely available for use beyond the hospital setting, for example in a physician's office or outpatient clinic.

"These additional CLIA waivers underscore the high quality and reliability of i-STAT cartridge technology and expand its potential beyond the hospital setting," said Greg Arnsdorff, vice president, point of care diagnostics, Abbott. "As these tests now become increasingly available in physicians' offices, more physicians will be able to provide their patients with treatment options in one visit, thereby improving the quality of care and eliminating the cost and hassle of a second appointment. "

The CLIA waivers indicate that these test cartridges are simple and accurate and can be made more broadly available to healthcare providers where fast results are needed such as physicians' offices, outpatient clinics, imaging centers, catheterization labs, as well as emergency departments, intensive care units, operating rooms, and military bases. By providing these critical test results rapidly, health care providers can quickly monitor and effectively manage their patients' care.

The i-STAT(R) System

The i-STAT System accelerates the availability of critical test information that clinicians require to make rapid triage and treatment decisions when diagnosing a patient's condition or monitoring a patient's treatment response. Weighing only 18 ounces, the i-STAT System is an easy-to- use handheld 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, outpatient clinics and physician offices.

About Abbott Point of Care

Abbott Point of Care, headquartered in Princeton, NJ, 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 handheld blood analyzer capable of performing a panel of commonly ordered blood tests on two or three drops of blood at the patient's side. (http://www.abbottpointofcare.com)

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 more than 68,000 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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