QNJ · Class II · 21 CFR 866.3378

FDA Product Code QNJ: Mass Spectrometry, Microorganism Identification, Blood Culture

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.

Leading manufacturers include Accelerate Diagnostics, Inc..

2
Total
2
Cleared
283d
Avg days
2020
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 182d recently vs 384d historically

FDA 510(k) Cleared Mass Spectrometry, Microorganism Identification, Blood Culture Devices (Product Code QNJ)

2 devices
1–2 of 2
Cleared Sep 26, 2024
Accelerate Arc System
K240854
Accelerate Diagnostics, Inc.
Microbiology · 182d

About Product Code QNJ - Regulatory Context

510(k) Submission Activity

2 total 510(k) submissions under product code QNJ since 2020, with 2 receiving FDA clearance (average review time: 283 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

Recent submissions under QNJ have taken an average of 182 days to reach a decision - down from 384 days historically, suggesting improved FDA processing for this classification.

QNJ devices are reviewed by the Microbiology panel. Browse all Microbiology devices →