MADISON, N.J.—HemoCueAB said June 18 that the U.S. Food and Drug Administration has cleared the company’s chronic-kidney-disease testing unit so it can be used more widely by healthcare professionals.
In 1988, the Clinical Laboratory Improvement Amendments established federal quality standards for the lab testing industry. CLIA waivers are given to FDA-approved products that are “simple” and have an “insignificant risk of producing an erroneous result.”
With the FDA waiver, non-laboratory trained physicians and other healthcare professionals in any healthcare facility with a CLIA waiver can use the HemoCue Albumin 201 System to screen patients for microalbuminuria.
The HemoCue Albumin 201 System received FDA 510(k) clearance in the first quarter of 2006.
Microalbuminuria is a condition in which albumin, a protein, is excreted in urine. It may indicate the presence of chronic kidney disease and is also an independent risk factor for developing cardiovascular disease in patients with or without diabetes or hypertension.
The HemoCue Albumin 201 System identifies low levels of albumin to screen, diagnosing, monitoring and to supplement clinical evidence in the treatment of microalbuminuria, according to HemoCue, which is a subsidiary of Quest Diagnostics. The test can produce results within 90 seconds.
"Given that microalbuminuria is a risk marker for cardiovascular disease, and its increase over time can indicate kidney disease, it is important that physicians have a fast, easy, reliable test to assess changes in their patients," said professor George L. Bakris, MD, director of the Hypertensive Diseases Unit at the University of Chicago-Pritzker School of Medicine. "The availability of a point-of-care test that accurately measures albumin in urine is expected to have a positive impact on physicians' ability to screen in-office and then begin treatment for patients at risk for microalbuminuria, such as those with diabetes or hypertension."
