SAN — Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples Class II
FDA product code SAN covers "Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples", a Class II medical device regulated under 21 CFR 866.1650. Submissions are reviewed by the Microbiology panel. At least 8 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- SAN
- Device Class
- Class II
- Regulation Number
- 866.1650
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
Automated system that performs antimicrobial susceptibility testing using positive blood culture samples
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260160 | biomerieux | VITEK REVEAL GN AST Assay and VITEK REVEAL AST System | July 8, 2026 |
| K253316 | phast | PhAST instrument and PhAST Blood Culture Gram-negative Panel | June 26, 2026 |
| K253573 | q-linea | ASTar BC G- Kit | April 15, 2026 |
| K251875 | affinity biosensors | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system | October 27, 2025 |
| K241324 | affinity biosensors | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system | October 23, 2024 |
| K230675 | specific diagnostics | VITEK REVEAL GN AST Assay and VITEK REVEAL AST System | June 20, 2024 |
| K221688 | q-linea | ASTar BC G- Kit and ASTar Instrument | April 26, 2024 |
| K211815 | affinity biosensors | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System | April 2, 2024 |