ASTar BC G- Kit and ASTar Instrument
FDA 510(k) K221688 · Q-Linea AB
510(k) numberK221688
Submission
- Device name
- ASTar BC G- Kit and ASTar Instrument
- Applicant
- Q-Linea AB
Uppsala, SE - Received
- June 10, 2022
- Decision date
- April 26, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- SAN – Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1650
- Specialty
- Microbiology
Automated system that performs antimicrobial susceptibility testing using positive blood culture samples
Other 510(k)s with product code SAN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260160 | VITEK REVEAL GN AST Assay and VITEK REVEAL AST SystemSAN · Traditional | bioMerieux, Inc. | 07/08/2026SE |
| K253316 | PhAST instrument and PhAST Blood Culture Gram-negative PanelSAN · Traditional | Phast Corp. | 06/26/2026SE |
| K253573 | ASTar BC G- KitSAN · Traditional | Q-Linea AB | 04/15/2026SE |
| K251875 | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST systemSAN · Traditional | Affinity Biosensors, LLC | 10/27/2025SE |
| K241324 | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST systemSAN · Traditional | Affinity Biosensors, LLC | 10/23/2024SE |
| K230675 | VITEK REVEAL GN AST Assay and VITEK REVEAL AST SystemSAN · Traditional | Specific Diagnostics, LLC | 06/20/2024SE |
| K211815 | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST SystemSAN · Traditional | Affinity Biosensors | 04/02/2024SE |
More from Affinity Biosensors
| 510(k) | Device | Decision |
|---|---|---|
| K253573 | ASTar BC G- KitSAN · Traditional | 04/15/2026SE |
Questions and answers
When was ASTar BC G- Kit and ASTar Instrument cleared by the FDA?
ASTar BC G- Kit and ASTar Instrument (K221688) received a 510(k) decision of Substantially Equivalent on April 26, 2024, 686 days after the submission was received.
What is the product code of K221688?
The FDA product code is SAN – Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples, a Class II (moderate risk) device regulated under 21 CFR 866.1650.