Devices · Accelerate Diagnostics, Inc.

Accelerate Pheno System, Accelerate PhenoTest BC Kit

Accelerate Diagnostics, Inc. is listed for Accelerate Pheno System, Accelerate PhenoTest BC Kit (K192665). The FDA list gives September 15, 2020 as the date of the final decision. The lead panel is Microbiology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code PRH as “Positive Blood Culture Identification And Ast Kit”: Fluorescence in situ hybridization (FISH) identification and quantitative, antimicrobial susceptibility testing (AST) kit intended for simultaneous detection and identification of multiple microbial targets. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K192665

Official FDA database record

Date of final decision

September 15, 2020

Company on the FDA list

Accelerate Diagnostics, Inc.

Lead panel

Microbiology

Primary product code

PRH

openFDA device name for the code

Positive Blood Culture Identification And Ast Kit

Device class

2

Regulation number

866.1650

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary