LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system

LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system is an FDA 510(k)-cleared medical device (K251875) manufactured by Affinity Biosensors, LLC. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 26, 2025. Regulation: 8.