In Brief: Incstar
This article was originally published in The Gray Sheet
Executive Summary
Incstar: Receives 510(k) clearance for a first generation complement activation enzyme (CAE) assay used to provide "general information about the immune system in certain disease states," including systemic lupus erythematosus, rheumatic disorders, "certain rare connective tissue disorders and massive tissue injury." The Stillwater, Minnesota-based immunodiagnostics firm says its CAE kit offers: "one year stability compared to two weeks" with competitors' products, the capability of performing large volume testing "in less than three hours," and reduced "hands on time in assay performance"...