FDA Clears New Handheld Instrument to Screen and Monitor Cholesterol

Lifestream Technologies Inc. announced that it has received 510(k) clearance from FDA to market the Cholestron Pro, a handheld instrument that accurately screens and monitors total cholesterol levels.

Requiring just one drop of blood and costing the patient less than $10 per test, the Cholestron Pro pinpoints a patient's total cholesterol level in about three minutes, producing accurate results without patient fasting. An initial screening identifies cholesterol levels high enough to warrant a full-lipid profile-a standardized laboratory test that requires patient fasting and allows physicians to accurately diagnose CHD-and a behavior modification or drug therapy program.

The instrument is used in conjunction with a patented disposable chemical test strip developed in collaboration with Roche Boehringer Mannheim.