FDA 510(k) approval for STC Technologies:
This article was originally published in Clinica
A cotinine test developed by STC Technologies has received 510(k) clearance from the FDA. The Auto-Lyte is a semi-quantitative test which measures cotinine, the major metabolite of nicotine, in urine samples. The company claims the test is sensitive enough to detect low levels of nicotine exposure such as second-hand smoke and can be run on most clinical chemistry analysers used by hospitals and clinical reference laboratories.