FDA Product Code SAN: Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
Automated System That Performs Antimicrobial Susceptibility Testing Using Positive Blood Culture Samples
Leading manufacturers include Q-Linea AB, Affinity Biosensors, LLC and Affinity Biosensors.
7
Total
7
Cleared
414d
Avg days
2024
Since
Growing category -
4 submissions in the last 2 years
vs 3 in the prior period
Review times improving: avg
179d
recently vs 727d historically
FDA 510(k) Cleared Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples Devices (Product Code SAN)
7 devices
Cleared
Apr 15, 2026
ASTar BC G- Kit
Q-Linea AB
Microbiology
149d
Cleared
Oct 27, 2025
LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system
Affinity Biosensors, LLC
Microbiology
131d
Cleared
Oct 23, 2024
LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system
Affinity Biosensors, LLC
Microbiology
166d
Cleared
Jun 20, 2024
VITEK REVEAL GN AST Assay and VITEK REVEAL AST System
Specific Diagnostics, LLC
Microbiology
468d
Cleared
Apr 26, 2024
ASTar BC G- Kit and ASTar Instrument
Q-Linea AB
Microbiology
686d
Cleared
Apr 02, 2024
LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System
Affinity Biosensors
Microbiology
1026d
About Product Code SAN - Regulatory Context
510(k) Submission Activity
7 total 510(k) submissions under product code SAN since 2024, with 7 receiving FDA clearance (average review time: 414 days).
Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - SAN Product Code
Recent submissions under SAN have taken an average of 179 days to reach a decision - down from 727 days historically, suggesting improved FDA processing for this classification.
SAN devices are reviewed by the Microbiology panel. Browse all Microbiology devices →