Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing
The positive blood culture processor for inoculum preparation used for antimicrobial susceptibility testing (product code QZX) is a Class 2 Microbiology device (regulation 866.1650) that includes associated reagents and is intended to recover microbes from positive blood cultures to prepare an inoculum for subsequent use in antimicrobial susceptibility testing. It requires 510(k) clearance. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QZX
- Device Class
- FDA class 2
- Regulation Number
- 866.1650
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K244044 | PBC Separator with Selux AST System | Mar 28, 2025 | Substantially Equivalent | Selux Diagnostics, Inc. |
| K223493 | PBC Separator with Selux AST System | Feb 15, 2024 | Substantially Equivalent | Selux Diagnostics, Inc. |
| K231536 | eQUANT System | Feb 08, 2024 | Substantially Equivalent | Avails Medical, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.