SAN · Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
Microbiology · 21 CFR 866.1650 · Class 2
Overview
| Product Code | SAN |
|---|---|
| Device Name | Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples |
| Regulation | 21 CFR 866.1650 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
Identification
A cellular analysis system for multiplexed antimicrobial susceptibility testing is a multiplex qualitative and/or quantitative in vitro diagnostic device intended for the identification and determination of the antimicrobial susceptibility results of organisms detected in samples from patients with suspected microbial infections. This device is intended to aid in the determination of antimicrobial susceptibility or resistance when used in conjunction with other laboratory findings.
Classification Rationale
Class II (special controls). The special controls for this device are:
Special Controls
*Classification.* Class II (special controls). The special controls for this device are:(1) Design verification and validation must include: (i) Detailed device description documentation, including the device components, ancillary reagents required but not provided, a detailed explanation of the methodology, including primer/probe sequence, design, rationale for sequence selection, and details of the antimicrobial agents, as applicable. (ii) Detailed documentation from the following analytical and clinical performance studies: limit of detection, inclusivity, precision, reproducibility, interference, cross-reactivity, carryover, and cross-contamination, quality control and additional studies, as applicable to specimen type and assay intended use. (iii) Detailed documentation from an appropriate clinical study. The study, performed on a study population consistent with the intended use population, must compare the device performance to results obtained from well-accepted reference methods. (iv) Detailed documentation for device software, including software applications and hardware-based devices that incorporate software. (2) The labeling required under § 809.10(b) of this chapter must include: (i) Limitations and protocols regarding the need for correlation of results by standard laboratory procedures, as applicable. (ii) A detailed explanation of the interpretation of results and acceptance criteria. (iii) A detailed explanation of the principles of operation and procedures for assay performance and troubleshooting.
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253573 | ASTar BC G- Kit | Q-Linea AB | Apr 15, 2026 | SESE |
| K251875 | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system | Affinity Biosensors, LLC | Oct 27, 2025 | SESE |
| K241324 | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system | Affinity Biosensors, LLC | Oct 23, 2024 | SESE |
| K230675 | VITEK REVEAL GN AST Assay and VITEK REVEAL AST System | Specific Diagnostics, LLC | Jun 20, 2024 | SESE |
| K221688 | ASTar BC G- Kit and ASTar Instrument | Q-Linea AB | Apr 26, 2024 | SESE |
| K211815 | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System | Affinity Biosensors | Apr 2, 2024 | SESE |
Top Applicants
- Affinity Biosensors, LLC — 2 clearances
- Q-Linea AB — 2 clearances
- Affinity Biosensors — 1 clearance
- Specific Diagnostics, LLC — 1 clearance
