Cleared Traditional

K192665 - Accelerate Pheno System, Accelerate PhenoTest BC Kit (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K192665 · Accelerate Diagnostics, Inc. · Microbiology device
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Sep 2020
Decision
356d
Days
Class 2
Risk

K192665 is an FDA 510(k) clearance 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 Diagnostics, Inc. (Tucson, US). The FDA issued a Cleared decision on September 15, 2020 after a review of 356 days - an unusually long review period, suggesting complex equivalence evaluation.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Accelerate Diagnostics, Inc. devices

Submission Details

510(k) Number K192665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2019
Decision Date September 15, 2020
Days to Decision 356 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
254d slower than avg
Panel avg: 102d · This submission: 356d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.