Abbott obtains FDA CLIA waiver for five additional test cartridges

According to the company, 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, the company said.

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.

The Clinical Laboratory Improvement Amendments (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.

Greg Arnsdorff, vice president of point of care diagnostics at Abbott, said: These additional CLIA waivers underscore the high quality and reliability of i-STAT cartridge technology and expand its potential beyond the hospital setting.