Clinical Chemistry · 12 clearances · 7 unique sponsors
| Sponsor | Clearances | Last 12 mo | Most recent |
|---|---|---|---|
| Beckman Coulter, Inc. | 4 | 0 | 2025-08-01 |
| Abbott Laboratories Diagnostics Division | 2 | 0 | 2023-05-04 |
| Abbott Point of Care, Inc. | 2 | 1 | 2026-06-11 |
| Siemens Healthcare Diagnostics, Inc. | 1 | 0 | 2024-07-25 |
| Ortho-Clinical Diagnostics, Inc. | 1 | 1 | 2025-10-29 |
| Roche Diagnostics | 1 | 0 | 2021-09-21 |
| Phc Corporation | 1 | 0 | 2024-03-20 |
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 |
|---|---|---|---|---|
| 84484 | CPT | — | High | Troponin, quantitative; including isoforms by immunoassay |
| 85999 | CPT | — | Low | Unlisted hematology/coagulation procedure when specific troponin code unavailable |
| Date | K-number | Sponsor | Device |
|---|---|---|---|
| 2026-06-11 | K253051 | Abbott Point of Care, Inc. | i-STAT hs-TnI cartridge with the i-STAT Alinity System |
| 2025-10-29 | K252393 | Ortho-Clinical Diagnostics, Inc. | VITROS Immunodiagnostic Products hs Troponin I Reagent Pack |
| 2025-08-01 | K243483 | Beckman Coulter, Inc. | Access hsTnI |
| 2025-06-16 | K242870 | Beckman Coulter, Inc. | Access hsTnI |
| 2025-01-03 | K240984 | Abbott Point of Care, Inc. | i-STAT hs-TnI cartridge with the i-STAT 1 System |
| 2024-07-25 | K241165 | Siemens Healthcare Diagnostics, Inc. | Atellica® IM High-Sensitivity Troponin I (TnIH) |
| 2024-03-20 | K231974 | Phc Corporation | PATHFAST®hs-cTnI-II |
| 2023-12-18 | K222881 | Beckman Coulter, Inc. | Access hsTnI |
| 2023-12-04 | K230648 | Beckman Coulter, Inc. | Access hsTnI |
| 2023-05-04 | K230994 | Abbott Laboratories Diagnostics Division | Alinity i STAT High Sensitivity Troponin-I |
| 2022-05-19 | K202525 | Abbott Laboratories Diagnostics Division | Alinity i STAT High Sensitivity Troponin-I |
| 2021-09-21 | K201441 | Roche Diagnostics | Elecsys Troponin T Gen 5 |