Device class
Class II
Regulation 866.1650
Total clearances
8
2024-04-02 → 2026-07-08
Definition
What is Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
Automated system that performs antimicrobial susceptibility testing using positive blood culture samples
Classification details
Medical specialty
Microbiology
Regulation number
866.1650
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Affinity Biosensors, LLC
|
3 |
1 |
2025-10-27 |
|
Q-Linea AB |
2 |
1 |
2026-04-15 |
|
bioMerieux, Inc.
|
1 |
1 |
2026-07-08 |
|
Specific Diagnostics, LLC |
1 |
0 |
2024-06-20 |
|
Phast Corp. |
1 |
1 |
2026-06-26 |
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 87186 |
CPT
|
— |
High
|
CPT for antimicrobial susceptibility testing using automated system, direct match for blood culture AST |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-07-08 |
K260160 |
bioMerieux, Inc.
|
VITEK REVEAL GN AST Assay and VITEK REVEAL AST System |
| 2026-06-26 |
K253316 |
Phast Corp.
|
PhAST instrument and PhAST Blood Culture Gram-negative Panel |
| 2026-04-15 |
K253573 |
Q-Linea AB
|
ASTar BC G- Kit |
| 2025-10-27 |
K251875 |
Affinity Biosensors, LLC
|
LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system |
| 2024-10-23 |
K241324 |
Affinity Biosensors, LLC
|
LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system |
| 2024-06-20 |
K230675 |
Specific Diagnostics, LLC
|
VITEK REVEAL GN AST Assay and VITEK REVEAL AST System |
| 2024-04-26 |
K221688 |
Q-Linea AB
|
ASTar BC G- Kit and ASTar Instrument |
| 2024-04-02 |
K211815 |
Affinity Biosensors
|
LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System |