K221688 is an FDA 510(k) clearance for the ASTar BC G- Kit and ASTar Instrument. This device is classified as a Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples (Class II - Special Controls, product code SAN).
Submitted by Q-Linea AB (Uppsala, SE). The FDA issued a Cleared decision on April 26, 2024, 686 days after receiving the submission on June 10, 2022.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1650. Automated System That Performs Antimicrobial Susceptibility Testing Using Positive Blood Culture Samples.
| 510(k) Number | K221688 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 10, 2022 |
| Decision Date | April 26, 2024 |
| Days to Decision | 686 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | SAN - Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1650 |
| Definition | Automated System That Performs Antimicrobial Susceptibility Testing Using Positive Blood Culture Samples |