Abbott receives FDA approval to market handheld blood analyzer

By E. Janene Geiss

Philadelphia, Jan. 25 - Abbott announced Wednesday that it has received 510(k) clearance from the Food and Drug Administration to market its i-STAT CHEM 8+ cartridge, a new point-of-care diagnostic test used to quickly assess basic metabolic status of patients in emergency rooms, clinics, surgical suites and other critical care settings.

The CHEM 8+ cartridge is designed for use with the i-STAT, a market-leading automated handheld blood analyzer that performs a comprehensive panel of critical tests at the patient's bedside in only a few minutes, producing lab-quality results that allow health care professionals to make on-the-spot diagnosis and treatment decisions for their patients, according to a company news release.

The new CHEM 8+ cartridge is a single-use, in vitro diagnostic test that combines a battery of basic metabolic tests, including sodium, potassium, chloride, ionized calcium, total CO(2), glucose, blood urea nitrogen and creatinine, with measurements for hematocrit and hemoglobin into a single test.

The test provides a rapid snapshot of the most critical homeostatic processes: glycemic control, electrolyte balance and renal function using just a few drops of blood, officials said.

"This new test represents a significant advance in our development of a portfolio of products that address the needs of the emergency department," Greg Arnsdorff, president, Abbott Point of Care, said in the release. "By providing critical, lab-quality test results in about two minutes, the CHEM 8+ cartridge and the rest of the i-STAT menu of assays can help facilitate a clinician's ability to make quick, accurate and informed decisions at the patient's bedside."

Abbott Point of Care, based in East Windsor, N.J., develops, manufactures and markets critical medical diagnostic and data management products for rapid blood analysis.

Based in Abbott Park, Ill., Abbott is a broad-based health care company devoted to the development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics.

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