DeviceClearance

Product code QNJ— Microbiology

Accelerate Arc System

Classification name
Mass Spectrometry, Microorganism Identification, Blood Culture
Device class
Class 2
Regulation
21 CFR 866.3378
Advisory panel
Microbiology
Total cleared
2
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code QNJ under 21 CFR 866.3378, via openFDA

Market context for product code QNJ

FDA has cleared 2 devices under product code QNJ between 2020 and 2024, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QNJ

Recent clearances under product code QNJ

Data sourced from openFDA. This site is unofficial and independent of the FDA.