K223493 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 February 15, 2024, 451 days after receiving the submission on November 21, 2022.
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 | K223493 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 2022 |
| Decision Date | February 15, 2024 |
| Days to Decision | 451 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. |