510(k) Report

Devices descending from DEN160032

12 later devices reach Accelerate Pheno system, Accelerate Phenotest BC Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253316PhAST instrument and PhAST Blood Culture Gram-negative PanelPhast Corp.20260—
+1K230675VITEK REVEAL GN AST Assay and VITEK REVEAL AST SystemSpecific Diagnostics, LLC20241—
+1K221688ASTar BC G- Kit and ASTar InstrumentQ-Linea AB20241—
+1K192665Accelerate Pheno System, Accelerate PhenoTest BC KitAccelerate Diagnostics, Inc.202062
+2K260160VITEK REVEAL GN AST Assay and VITEK REVEAL AST SystembioMerieux, Inc.20260—
+2K253573ASTar BC G- KitQ-Linea AB20260—
+2K211815LifeScale Gram Negative Kit (LSGN) with the LifeScale AST SystemAffinity Biosensors20242—
+2K231536eQUANT SystemAvails Medical, Inc.20242—
+3K251875LifeScale Gram Negative Kit (LSGN) with the LifeScale AST systemAffinity Biosensors, LLC20250—
+3K241324LifeScale Gram Negative Kit (LSGN) with the LifeScale AST systemAffinity Biosensors, LLC20241—
+3K223493PBC Separator with Selux AST SystemSelux Diagnostics, Inc.20241—
+4K244044PBC Separator with Selux AST SystemSelux Diagnostics, Inc.20250—