FDA product code SAN: Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
SAN is the FDA product code for automated antimicrobial susceptibility test system for positive blood culture samples. It is a Class II device, regulated under 21 CFR 866.1650 and reviewed by the Microbiology panel. FDA has cleared 8 510(k) submissions under SAN, 8 in the last five years, from 6 different applicants. The average 510(k) review took 383 days (median 219); 304 days on average over the last three years.
Definition
Automated system that performs antimicrobial susceptibility testing using positive blood culture samples
Classification
| Field | Value |
|---|---|
| Device name | Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples |
| Device class | Class II |
| Regulation | 21 CFR 866.1650 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for SAN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 4 | 586 |
| 2025 | 1 | 131 |
| 2026 | 3 | 196 |
Compare with all 510(k) review times · Search every SAN clearance
Top SAN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Q-Linea AB | 2 | 2026-04-15 |
| Affinity Biosensors, LLC | 2 | 2025-10-27 |
| bioMerieux, Inc. | 1 | 2026-07-08 |
| Phast Corp. | 1 | 2026-06-26 |
| Specific Diagnostics, LLC | 1 | 2024-06-20 |
1 more applicants have SAN clearances. See the full list in Caduvo.
Most recent SAN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260160 | bioMerieux, Inc. | VITEK REVEAL GN AST Assay and VITEK REVEAL AST System | 2026-07-08 | 169 |
| K253316 | Phast Corp. | PhAST instrument and PhAST Blood Culture Gram-negative Panel | 2026-06-26 | 269 |
| K253573 | Q-Linea AB | ASTar BC G- Kit | 2026-04-15 | 149 |
| K251875 | Affinity Biosensors, LLC | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system | 2025-10-27 | 131 |
| K241324 | Affinity Biosensors, LLC | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system | 2024-10-23 | 166 |
Recalls for SAN devices
openFDA lists no recalls for product code SAN.
Frequently asked questions
What is FDA product code SAN?
SAN is the FDA product code for automated antimicrobial susceptibility test system for positive blood culture samples. It is a Class II device, regulated under 21 CFR 866.1650 and reviewed by the Microbiology panel.
What device class is SAN?
Class II, regulation 21 CFR 866.1650. Typical premarket route: 510(k).
How long does a 510(k) take for product code SAN?
Across 8 cleared submissions the average was 383 days from receipt to decision (median 219).
Which companies have the most SAN clearances?
Q-Linea AB (2); Affinity Biosensors, LLC (2); bioMerieux, Inc. (1); Phast Corp. (1); Specific Diagnostics, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SAN
- Run a recall and safety report across every SAN manufacturer
- Watch product code SAN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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