510(k) Report

Devices descending from K192665

6 later devices reach Accelerate Pheno System, Accelerate PhenoTest BC Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211815LifeScale Gram Negative Kit (LSGN) with the LifeScale AST SystemAffinity Biosensors20242—
+1K231536eQUANT SystemAvails Medical, Inc.20242—
+2K251875LifeScale Gram Negative Kit (LSGN) with the LifeScale AST systemAffinity Biosensors, LLC20250—
+2K241324LifeScale Gram Negative Kit (LSGN) with the LifeScale AST systemAffinity Biosensors, LLC20241—
+2K223493PBC Separator with Selux AST SystemSelux Diagnostics, Inc.20241—
+3K244044PBC Separator with Selux AST SystemSelux Diagnostics, Inc.20250—