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 Bruker Daltonik GmbH and Accelerate Diagnostics, Inc..
2
Total
2
Cleared
283d
Avg days
2020
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Mass Spectrometry, Microorganism Identification, Blood Culture Devices (Product Code QNJ)
2 devices
Cleared
Sep 26, 2024
Accelerate Arc System
Accelerate Diagnostics, Inc.
Microbiology
182d
Cleared
Dec 27, 2020
MBT Sepsityper
Bruker Daltonik GmbH
Microbiology
384d
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 declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.