FDA OK's Abbott's Use of Blood Analyzer with CLIA Waiver

 

October 2, 2007

October 2, 2007 - Abbott said the FDA has granted waived status under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for its hand-held 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, healthcare 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.

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 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 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.

The company says the i-STAT is currently used in more than 1,800 hospitals.

For more information: www.abbott.com