Not Cleared Direct

DEN160032 - Accelerate Pheno system, Accelerate Phenotest BC Kit (FDA 510(k) Clearance)

Class II Microbiology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN160032 · Accelerate Diagnotics · Microbiology device
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Feb 2017
Decision
227d
Days
Class 2
Risk

DEN160032 is an FDA 510(k) submission (not cleared) for the Accelerate Pheno system, Accelerate Phenotest BC Kit. Classified as Positive Blood Culture Identification And Ast Kit (product code PRH), Class II - Special Controls.

Submitted by Accelerate Diagnotics (Tucson, US). The FDA issued a Not Cleared (DENG) decision on February 23, 2017 after a review of 227 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1650 - the FDA microbiology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Microbiology review framework.

View all Accelerate Diagnotics devices

Submission Details

510(k) Number DEN160032 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received July 11, 2016
Decision Date February 23, 2017
Days to Decision 227 days
Submission Type Direct
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
125d slower than avg
Panel avg: 102d · This submission: 227d
Pathway characteristics

Device Classification

Product Code PRH Positive Blood Culture Identification And Ast Kit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1650
Definition Fluorescence In Situ Hybridization (fish) Identification And Quantitative, Antimicrobial Susceptibility Testing (ast) Kit Intended For Simultaneous Detection And Identification Of Multiple Microbial Targets.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.