Product code SAN— Microbiology
LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system
- Classification name
- Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
- Device class
- Class 2
- Regulation
- 21 CFR 866.1650
- Advisory panel
- Microbiology
- Total cleared
- 8
- First cleared
- Most recent
FDA classification definition
“Automated system that performs antimicrobial susceptibility testing using positive blood culture samples”
Market context for product code SAN
FDA has cleared devices under product code SAN between 2024 and 2026, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2026
- 2025
- 2024
Top applicants under product code SAN
Recent clearances under product code SAN
- K260160 — VITEK REVEAL GN AST Assay and VITEK REVEAL AST System
- K253316 — PhAST instrument and PhAST Blood Culture Gram-negative Panel
- K253573 — ASTar BC G- Kit
- K251875 — LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system
- K241324 — LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system
- K230675 — VITEK REVEAL GN AST Assay and VITEK REVEAL AST System
- K221688 — ASTar BC G- Kit and ASTar Instrument
- K211815 — LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System
Data sourced from openFDA. This site is unofficial and independent of the FDA.