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FDA Grants CLIA Waiver To Abbott To Use Five Additional Cartridges On The i-STAT Handheld Blood Analyzer

Abbott has announced that the US 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. "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."