510(k) · Cleared
ClearedAccelerate Arc System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Accelerate Diagnostics, Inc. · QNJ Mass Spectrometry, Microorganism Identification, Blood Culture
Cleared on Sep 26, 2024 as substantially equivalent to K193419 (Bruker Daltonik GmbH, 2020) after a 182-day review. Its family tree reaches back 1 generation to 2020.
- Decided
- Sep 26, 2024
- Review
- 182 days
- Class
- Class II
- Product code
- QNJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K193419 (2020). No later device cites it as a predicate yet.
- Root · 1 generation backK193419 MBT SepsityperBruker Daltonik GmbH · 2020
- This deviceK240854 Accelerate Arc SystemAccelerate Diagnostics, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K193419 | MBT Sepsityper | Bruker Daltonik GmbH | 2020 | — |
| 0 (this device) | K240854 | Accelerate Arc System | Accelerate Diagnostics, Inc. | 2024 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QNJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K193419 | MBT SepsityperSummary page 10…s. J. Substantial Equivalence Information 1. Predicate Device Name: MBT Sepsityper 2. Predicate 510(k) Number: K193419 3. Comparison with Predicate: A comparison of the features of the Accelerate Arc system and the MBT Sepsityper,… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K193419.
How does its category compare?
All QNJ devicesQNJ Mass Spectrometry, Microorganism Identification, Blood Culture: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QNJ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QNJ
Too few QNJ 510(k)s in any year since 2007 to give a median.
Recalls per year · QNJ
No recall names QNJ since 2007.
Adverse event reports per year · QNJ
No MAUDE report names QNJ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Accelerate Arc system is an automated sample preparation device that uses lysis and centrifugation to prepare concentrated microbial suspensions from positive blood culture samples that can be used for bacterial and yeast identification with the Bruker MALDI Biotyper CA System (MBT-CA System) with MBT-CA Sepsityper software extension. Samples are processed directly from BD BACTEC blood culture bottles identified as positive by a continuous monitoring…
Read the full statement (237 words)
The Accelerate Arc system is an automated sample preparation device that uses lysis and centrifugation to prepare concentrated microbial suspensions from positive blood culture samples that can be used for bacterial and yeast identification with the Bruker MALDI Biotyper CA System (MBT-CA System) with MBT-CA Sepsityper software extension. Samples are processed directly from BD BACTEC blood culture bottles identified as positive by a continuous monitoring blood culture system. Samples should be confirmed as monomicrobial by Gram stain.
The Accelerate Arc system is an in vitro diagnostic device comprised of the Accelerate Arc instrument, Accelerate Arc system software, and the Accelerate Arc BC kit. The Accelerate Arc BC kit is a disposable consumable that includes reagents to concentrate and purify microbial cells from positive blood culture samples.
Microbial suspensions prepared by the Accelerate Arc system can be used to identify bacterial species and yeasts in accordance with the Bruker MBT-CA reference library.
Subculture of positive blood culture is necessary to recover organisms not identified by the Bruker MBT-CA System with MBT-CA Sepsityper software extension, species not indicated for testing with the Bruker MBT-CA System with MBT-CA Sepsityper software extension, for susceptibility testing, for epidemiologic testing, and for differentiation/recovery of organisms present in polymicrobial samples.
The Accelerate Arc system is intended for use by trained healthcare professionals in clinical laboratories in conjunction with other clinical and laboratory findings, including Gram staining, to aid in the diagnosis of bloodstream infections.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240854 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240854: Accelerate Arc System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240854
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026