SAN · Class II · 21 CFR 866.1650

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.

8
Total
8
Cleared
383d
Avg days
2024
Since
Growing category - 5 submissions in the last 2 years vs 3 in the prior period
Review times improving: avg 177d recently vs 727d historically

FDA 510(k) Cleared Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples Devices (Product Code SAN)

8 devices
1–8 of 8
Cleared Jul 08, 2026
VITEK REVEAL GN AST Assay and VITEK REVEAL AST System
K260160
bioMerieux, Inc.
Microbiology · 169d
Cleared Apr 15, 2026
ASTar BC G- Kit
K253573
Q-Linea AB
Microbiology · 149d
Cleared Oct 27, 2025
LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system
K251875
Affinity Biosensors, LLC
Microbiology · 131d
Cleared Oct 23, 2024
LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system
K241324
Affinity Biosensors, LLC
Microbiology · 166d
Cleared Jun 20, 2024
VITEK REVEAL GN AST Assay and VITEK REVEAL AST System
K230675
Specific Diagnostics, LLC
Microbiology · 468d
Cleared Apr 26, 2024
ASTar BC G- Kit and ASTar Instrument
K221688
Q-Linea AB
Microbiology · 686d
Cleared Apr 02, 2024
LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System
K211815
Affinity Biosensors
Microbiology · 1026d

About Product Code SAN - Regulatory Context

510(k) Submission Activity

8 total 510(k) submissions under product code SAN since 2024, with 8 receiving FDA clearance (average review time: 383 days).

Submission volume has increased in recent years - 5 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 177 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 →