K211815 is an FDA 510(k) clearance for the LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System. 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 Affinity Biosensors (Santa Barbara, US). The FDA issued a Cleared decision on April 2, 2024, 1026 days after receiving the submission on June 11, 2021.
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 | K211815 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 11, 2021 |
| Decision Date | April 02, 2024 |
| Days to Decision | 1026 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 |