K244044 is an FDA 510(k) clearance for the PBC Separator with Selux AST System. This device is classified as a Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing (Class II - Special Controls, product code QZX).
Submitted by Selux Diagnostics, Inc. (Charlestown, US). The FDA issued a Cleared decision on March 28, 2025, 88 days after receiving the submission on December 30, 2024.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1650. 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) Number | K244044 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 2024 |
| Decision Date | March 28, 2025 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | QZX - Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1650 |
| 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. |