FDA product code QNJ: Mass Spectrometry, Microorganism Identification, Blood Culture
QNJ is the FDA product code for mass spectrometry, microorganism identification, blood culture. It is a Class II device, regulated under 21 CFR 866.3378 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under QNJ, 1 in the last five years, from 2 different applicants. The average 510(k) review took 283 days (median 283); 182 days on average over the last three years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Mass Spectrometry, Microorganism Identification, Blood Culture |
| Device class | Class II |
| Regulation | 21 CFR 866.3378 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for QNJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 384 |
| 2024 | 1 | 182 |
Compare with all 510(k) review times · Search every QNJ clearance
Top QNJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Accelerate Diagnostics, Inc. | 1 | 2024-09-26 |
| Bruker Daltonik GmbH | 1 | 2020-12-27 |
Most recent QNJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K240854 | Accelerate Diagnostics, Inc. | Accelerate Arc System | 2024-09-26 | 182 |
| K193419 | Bruker Daltonik GmbH | MBT Sepsityper | 2020-12-27 | 384 |
Recalls for QNJ devices
openFDA lists no recalls for product code QNJ.
Frequently asked questions
What is FDA product code QNJ?
QNJ is the FDA product code for mass spectrometry, microorganism identification, blood culture. It is a Class II device, regulated under 21 CFR 866.3378 and reviewed by the Microbiology panel.
What device class is QNJ?
Class II, regulation 21 CFR 866.3378. Typical premarket route: 510(k).
How long does a 510(k) take for product code QNJ?
Across 2 cleared submissions the average was 283 days from receipt to decision (median 283).
Which companies have the most QNJ clearances?
Accelerate Diagnostics, Inc. (1); Bruker Daltonik GmbH (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QNJ
- Run a recall and safety report across every QNJ manufacturer
- Watch product code QNJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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