Cleared Traditional

K240854 - Accelerate Arc System (FDA 510(k) Clearance)

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

K240854 · Accelerate Diagnostics, Inc. · Microbiology device
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Sep 2024
Decision
182d
Days
Class 2
Risk

K240854 is an FDA 510(k) clearance for the Accelerate Arc System. Classified as Mass Spectrometry, Microorganism Identification, Blood Culture (product code QNJ), Class II - Special Controls.

Submitted by Accelerate Diagnostics, Inc. (Tucson, US). The FDA issued a Cleared decision on September 26, 2024 after a review of 182 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3378 - 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. Standard predicate reliance. 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 K240854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2024
Decision Date September 26, 2024
Days to Decision 182 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 102d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QNJ Mass Spectrometry, Microorganism Identification, Blood Culture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3378
Definition Blood Culture Processing Device That Includes Associated Reagents That Are Intended To Concentrate And Purify Microbial Cells From Blood Culture Samples Identified As Positive By A Continuous Monitoring Blood Culture System With Organisms Subsequently Identified By Spectrometry.
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.

Regulatory Consultant

Precision For Medicine, Inc.
Jo-Ann Gonzales

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.