# K240854: Accelerate Arc System

- Pathway: 510(k) (Traditional)
- Applicant: Accelerate Diagnostics, Inc.
- Decided: Sep 26, 2024 after 182 days
- Product code: QNJ (Mass Spectrometry, Microorganism Identification, Blood Culture)
- Device class: 2
- Regulation: 21 CFR 866.3378
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K193419 (2020). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193419: MBT Sepsityper, Bruker Daltonik GmbH (2020) Summary page 10.

## Indications for use
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.

Source page: https://510kreport.com/device/K240854
Methodology: https://510kreport.com/methodology