Abbott Receives FDA CLIA Waiver for Use of Five Additional Cartridges on the i-STAT Handheld Blood Analyzer

Tuesday, January 20, 2009 General News
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PRINCETON, N.J., Jan. 19 Abbott announced todaythat the U.S. Food and Drug Administration (FDA) has granted waived statusunder the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for fiveadditional test cartridges used by its i-STAT handheld blood analyzer.

Cartridges for E3+, EC4+ and 6+ aid the clinician in assessing a patient'smetabolic state within a few minutes. The glucose cartridge quickly deliversa patient's diagnostic blood glucose level. Creatinine is a measure andindicator of a patient's renal function right at the patient's side. The fiveare components of the CHEM8+ cartridge, which the FDA waived in 2007. TheCHEM8+ cartridge allows a clinician to run a basic chemistry panel on apatient together with hemoglobin and hematocrit tests. Waived status makesthese tests more widely available for use beyond the hospital setting, forexample in a physician's office or outpatient clinic.

"These additional CLIA waivers underscore the high quality and reliabilityof i-STAT cartridge technology and expand its potential beyond the hospitalsetting," 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 treatmentoptions in one visit, thereby improving the quality of care and eliminatingthe cost and hassle of a second appointment. "

The CLIA waivers indicate that these test cartridges are simple andaccurate and can be made more broadly available to healthcare providers wherefast 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 thesecritical test results rapidly, health care providers can quickly monitor andeffectively manage their patients' care.

The i-STAT(R) System

The i-STAT System accelerates the availability of critical testinformation that clinicians require to make rapid triage and treatmentdecisions when diagnosing a patient's condition or monitoring a patient'streatment response. Weighing only 18 ounces, the i-STAT System is an easy-to-use handheld analyzer capable of providing time-sensitive test results at thepatient's side in just minutes. To perform a test, the user places two orthree drops of whole blood on the test cartridge, which is then inserted intothe analyzer. A new test cartridge is used for each patient. Utilizing test-specific cartridges that are fully self-contained, the i-STAT System deliverslab-accurate testing for blood gases, electrolytes, chemistries, coagulation,hematology, glucose and cardiac markers. i-STAT is at the forefront ofexpanding the possibilities with the industry's most comprehensive panel ofbedside tests on a single platform. The i-STAT System is currently used inmore than 1,800 hospitals where rapid test results are critical for betterpatient care. The system is used in emergency departments, intensive careunits, operating rooms, as well as catheterization laboratories, outpatientclinics 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 managementproducts for rapid blood analysis. The company's premier product is the i-STAT, a market-leading handheld blood analyzer capable of performing a panelof commonly ordered blood tests on two or three drops of blood at thepatient's side. (

About Abbott

Abbott is a global, broad-based health care company devoted to thediscovery, development, manufacture and marketing of pharmaceuticals andmedical products, including nutritionals, devices and diagnostics. Thecompany employs more than 68,000 people and markets its products in more than130 countries.

Abbott's news releases and other information are available on thecompany's Web site at


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