FDA.reportPublic FDA data

Accelerate Pheno™ System

Primary DI
00862011000314
Brand
Accelerate Pheno™ System
Company
ACCELERATE DIAGNOSTICS, INC.
Model
10401008
Device description
The Accelerate Pheno™ system is a fully-integrated in vitro diagnostic system comprised of one to four module(s), a Control PC, Analysis PC(s), touchscreen monitor and Accelerate Pheno system software for use with Accelerate PhenoTest™ kits. It is designed to perform identification (ID) and quantitation of bacterial and yeast cells in less than 90 minutes and antimicrobial susceptibility testing (AST) on average in less than 7 hours directly from patient samples.Identification uses fluorescence in situ hybridization (FISH) and susceptibility testing uses microscopic observation of individual, live, growing bacterial cells in near real time (approximately every 10 minutes) in the presence of antimicrobial agents.
Published
2017-03-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NSUInstrumentation For Clinical Multiplex Test Systems
PRHPositive Blood Culture Identification And Ast Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSUInstrumentation For Clinical Multiplex Test SystemsClinical Chemistry2
PRHPositive Blood Culture Identification And Ast KitMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN160032000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN160032000Accelerate Pheno system, Accelerate Phenotest BC KitAccelerate Diagnotics2017-02-23PRH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10862011000311PackageGS11In Commercial Distribution
00862011000314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086201100031110862011000311
00862011000314008620110003148620110003140862011000314

GMDN Terms#

Term, Definition table
TermDefinition
Multiple bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acids and/or genes conferring antimicrobial resistance from multiple types of microorgansims associated with bloodstream infection (i.e., bacteria, fungi, and viruses) in a clinical specimen and/or culture isolate, using a nucleic acid amplification/mass spectrometry method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
186328670
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00862011000383Accelerate PhenoTest BC kit101040182021-11-04
10862011000335Accelerate PhenoTest BC ID QC test101051582018-02-01
10862011000342Accelerate PhenoTest BC AST QC test101061582018-02-01
00862011000352Accelerate PhenoTest® BC AST QC test101071582020-07-15
00862011000369Accelerate PhenoTest® BC kit 101020182020-07-15
00862011000307Accelerate PhenoTest™ BC Kit101010182017-03-20
00862011000321Accelerate Pheno™ System103010082017-03-20

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Primary DI, Brand, Company table
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