US clearance for Cholestech's ALT (alanine amino transferase) test:
This article was originally published in Clinica
Executive Summary
Cholestech has received a 510(k) clearance from the US FDA for its alanine amino transferase (ALT) liver function test. The ALT test will be run on the company's Cholestech LDX system, a telephone-sized device that can perform multiple simultaneous diagnostic tests from a single drop of blood to produce results in less than five minutes. Quantitative ALT measurements are used to help diagnose and treat certain liver disease, such as viral hepatitis and cirrhosis and heart disease, said the Hayward, California-based company.