Accelerate PhenoTest™ BC Kit

GUDID 00862011000307

The Accelerate PhenoTest™ BC kit is a multiplexed in vitro diagnostic test utilizing both qualitative nucleic acid fluorescence in situ hybridization (FISH) identification and quantitative, antimicrobial susceptibility testing (AST) methods and is intended for use with the Accelerate Pheno™ system. The Accelerate PhenoTest™ BC kit is capable of simultaneous detection and identification of multiple microbial targets followed by susceptibility testing of the appropriate detected bacterial organisms. The Accelerate PhenoTest™ BC kit is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system. Results are intended to be interpreted in conjunction with Gram stain results.

ACCELERATE DIAGNOSTICS, INC.

Multiple bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry

• Primary Device ID: 00862011000307
• NIH Device Record Key: f2d69497-fbb9-4e61-9f9c-c0dc1f0707b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accelerate PhenoTest™ BC Kit
• Version Model Number: 10101018
• Company DUNS: 186328670
• Company Name: ACCELERATE DIAGNOSTICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00862011000307 [Primary]
GS1	10862011000304 [Package]; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN160032

FDA Product Code

• NSU: Instrumentation For Clinical Multiplex Test Systems
• PRH: Positive Blood Culture Identification And Ast Kit

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-08-20
• Device Publish Date: 2017-03-20

Devices Manufactured by ACCELERATE DIAGNOSTICS, INC.

• 00862011000383 - Accelerate PhenoTest BC kit: 2021-11-12 The Accelerate PhenoTest® BC kit is a multiplexed in vitro diagnostic test utilizing both qualitative nucleic acid fluorescence
• 10862011000335 - Accelerate PhenoTest BC ID QC test: 2020-12-21 The Accelerate PhenoTest™ BC ID QC test is intended to serve as an external quality control to monitor the accuracy of the org
• 10862011000342 - Accelerate PhenoTest BC AST QC test: 2020-12-21 The Accelerate PhenoTest™ BC AST QC test is intended to serve as an external quality control to monitor the accuracy of the an
• 00862011000352 - Accelerate PhenoTest® BC AST QC test: 2020-07-23 The Accelerate PhenoTest® BC AST QC test is intended to serve as an external quality control to monitor the accuracy of the ant
• 00862011000369 - Accelerate PhenoTest® BC kit: 2020-07-23 The Accelerate PhenoTest® BC kit is a multiplexed in vitro diagnostic test utilizing both qualitative nucleic acid fluorescence
• 00862011000307 - Accelerate PhenoTest™ BC Kit: 2019-08-20The Accelerate PhenoTest™ BC kit is a multiplexed in vitro diagnostic test utilizing both qualitative nucleic acid fluorescence in situ hybridization (FISH) identification and quantitative, antimicrobial susceptibility testing (AST) methods and is intended for use with the Accelerate Pheno™ system. The Accelerate PhenoTest™ BC kit is capable of simultaneous detection and identification of multiple microbial targets followed by susceptibility testing of the appropriate detected bacterial organisms. The Accelerate PhenoTest™ BC kit is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system. Results are intended to be interpreted in conjunction with Gram stain results.
• 00862011000307 - Accelerate PhenoTest™ BC Kit: 2019-08-20 The Accelerate PhenoTest™ BC kit is a multiplexed in vitro diagnostic test utilizing both qualitative nucleic acid fluorescenc
• 00862011000314 - Accelerate Pheno™ System: 2019-08-20 The Accelerate Pheno™ system is a fully-integrated in vitro diagnostic system comprised of one to four module(s), a Control PC
• 00862011000321 - Accelerate Pheno™ System: 2019-08-20 The Accelerate Pheno™ system is a fully-integrated in vitro diagnostic system comprised of one to four module(s), a Control PC