Abbott Broadens Use of i-STAT Handheld Blood Analyzer with CLIA Waiver Granted by FDA for CHEM8+ Test Cartridge

03/10/07 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."