Last Updated: 2002-12-17 16:28:20 -0400 (Reuters Health)
WASHINGTON (Reuters) - A test that helps people with diabetes monitor their blood sugar levels can be sold over-the-counter, the US Food and Drug Administration said on Tuesday.
The FDA said it had cleared nonprescription sales of the test, called Metrika A1c Now.
"Over-the-counter status means that the test can now be purchased without a prescription and used at home, with results on the spot, making it readily available to people with diabetes," the agency said in a statement.
The test, made by privately held Metrika, Inc., of Sunnyvale, California, looks for levels of glycated hemoglobin in the blood. It helps patients and doctors monitor blood levels of sugar over time, as opposed to instant tests--now often available over the counter--that take an instant snapshot of levels.
"Glycated hemoglobin is a unique substance created as a result of interaction between hemoglobin and glucose," the FDA said. Hemoglobin is the stuff that makes blood red, and the reading helps patients know what their average blood sugar level was over the past 90 to 120 days.
It is useful in monitoring how well insulin or other diabetes medications are working.
To use the test, the patient pricks his or her finger and puts a drop of blood into a monitor, which reads the levels within eight minutes.
"Unlike some other products, there is no need to send the sample back to the physician to get results," the FDA said. "The patient gets the results on the spot."
An estimated 17 million Americans have diabetes, most of them type-II diabetes associated with obesity and a lack of exercise. "Many of them may find the new home glycated hemoglobin test helpful," the FDA said.