Company Gets 510(k) for Cystic Fibrosis Test

September 4, 2009
Luminex received clearance from the FDA for its xTAG Cystic Fibrosis 39 Kit v2, according to a company statement. The test detects for 39 CF-causing gene mutations and serves as an aid in newborn screening and confirmatory diagnostic testing in newborns and children. The device tests for 16 additional gene mutations to the 23 recommended by the American College of Medical Genetics and the American College of Obstericians and Gynecologists. Results are available in a few hours, the statement says.