ASTar BC G- Kit and ASTar Instrument
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Q-Linea AB
Identifiers
- 510(k) Number
- K221688 FDA 510(k)
- FDA Product Code
- SAN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.1650 FDA 510(k)
- Regulation Number
- 866.1650 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ASTar BC G- Kit and ASTar Instrument is an Automated Antimicrobial Susceptibility Test System for Positive Blood Culture Samples, designed to perform in vitro antimicrobial susceptibility testing (AST). This system automates the detection and quantification of bacterial growth in response to antimicrobial agents, enabling precise determination of minimum inhibitory concentrations (MICs) for clinically relevant pathogens. It is classified as a Class II medical device under FDA regulations and adheres to IVDR standards in the EU, ensuring compliance with microbiology testing protocols. The system integrates consumables, including sample preparation cartridges and antimicrobial discs, to streamline workflows in clinical microbiology laboratories.
The ASTar BC G- Kit and ASTar Instrument are supplied as a combined system, including the ASTar BC G- Kit (with consumables) and the ASTar Instrument for automated processing. The device is intended for single-use consumables, with the instrument designed for repeated use in controlled laboratory environments. It is not MRI-compatible and requires proper storage conditions to maintain sterility and functionality. The system holds FDA 510(k) clearance (K221688) and IVDR conformity, with regulatory filings under product code SAN and device classification 866.1650. No third-party certification is required for use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ASTar kits - Q-linea, ASTar Kit | Q-linea, Q-Linea AB FDA 510 (k) Products - Latest 2026, PDF K221688 - Food and Drug Administration
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K221688 | Class II | Active |
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Manufacturer
- Manufacturer
- Q-Linea AB
Sources (2)
- FDA 510(k) K221688 24 fields · synced Sep 20, 2026
- EUDAMED 1 fields · synced May 19, 2026