Two Point-of-Care Tests Receive FDA 510(k) Clearance

Quest Diagnostics’ HemoCue and Focus Diagnostics subsidiaries have received FDA 510(k) clearance for two new point-of-care tests.

This is the first step in the regulatory process that allows the companies to market the products and file for Clinical Laboratory Improvement Amendments waivers, which would enable the tests to be used in a much larger segment of physician offices, Quest said.

The HemoCue White Blood Cell Analyzer is a whole-blood test performed on finger-stick samples that assists physicians diagnosing infection, inflammation, bone marrow failure, autoimmune diseases, drug toxicity, leukemic neoplasia and many other medical conditions now routinely tested for by reference laboratories.

The company also received FDA clearance for Focus Diagnostics’ HerpeSelect Express HSV-2, a test for aiding in the diagnosis of the herpes simplex type-2 virus, the primary cause of genital herpes.