FDA product code QZX: Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing
QZX is the FDA product code for positive blood culture processor for inoculum preparation used for antimicrobial susceptibility testing. It is a Class II device, regulated under 21 CFR 866.1650 and reviewed by the Microbiology panel. FDA has cleared 3 510(k) submissions under QZX, 3 in the last five years, from 2 different applicants. The average 510(k) review took 264 days (median 254); 220 days on average over the last three years.
Definition
Processing device that includes associated reagents, when applicable, that is intended to recover microbes from positive blood cultures for inoculum preparation. The prepared inoculum is intended for subsequent use in antimicrobial susceptibility testing.
Classification
| Field | Value |
|---|---|
| Device name | Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing |
| Device class | Class II |
| Regulation | 21 CFR 866.1650 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for QZX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 2 | 352 |
| 2025 | 1 | 88 |
Compare with all 510(k) review times · Search every QZX clearance
Top QZX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Selux Diagnostics, Inc. | 2 | 2025-03-28 |
| Avails Medical, Inc. | 1 | 2024-02-08 |
Most recent QZX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K244044 | Selux Diagnostics, Inc. | PBC Separator with Selux AST System | 2025-03-28 | 88 |
| K223493 | Selux Diagnostics, Inc. | PBC Separator with Selux AST System | 2024-02-15 | 451 |
| K231536 | Avails Medical, Inc. | eQUANT System | 2024-02-08 | 254 |
Recalls for QZX devices
openFDA lists no recalls for product code QZX.
Frequently asked questions
What is FDA product code QZX?
QZX is the FDA product code for positive blood culture processor for inoculum preparation used for antimicrobial susceptibility testing. It is a Class II device, regulated under 21 CFR 866.1650 and reviewed by the Microbiology panel.
What device class is QZX?
Class II, regulation 21 CFR 866.1650. Typical premarket route: 510(k).
How long does a 510(k) take for product code QZX?
Across 3 cleared submissions the average was 264 days from receipt to decision (median 254).
Which companies have the most QZX clearances?
Selux Diagnostics, Inc. (2); Avails Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QZX
- Run a recall and safety report across every QZX manufacturer
- Watch product code QZX 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.
All Microbiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times