ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS
FDA 510(k) clearance K082699 · decided 2009-08-19
Clearance details
- K-number
- K082699
- Device name
- ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS
- Applicant
- Roche Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2008-09-15
- Decision date
- 2009-08-19
- Days to decision
- 338 days
- Clearance type
- Traditional
- Product code
- MMI
- Device class
- 2
- Regulation number
- 862.1215
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Roche Diagnostics
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| i-STAT hs-TnI cartridge with the i-STAT Alinity System (K253051) | Abbott Point of Care, Inc. | 2026-06-11 |
| VITROS Immunodiagnostic Products hs Troponin I Reagent Pack (K252393) | Ortho-Clinical Diagnostics, Inc. | 2025-10-29 |
| Access hsTnI (K243483) | Beckman Coulter, Inc. | 2025-08-01 |
| Access hsTnI (K242870) | Beckman Coulter, Inc. | 2025-06-16 |
| i-STAT hs-TnI cartridge with the i-STAT 1 System (K240984) | Abbott Point of Care, Inc. | 2025-01-03 |
| Atellica® IM High-Sensitivity Troponin I (TnIH) (K241165) | Siemens Healthcare Diagnostics, Inc. | 2024-07-25 |
| PATHFAST®hs-cTnI-II (K231974) | Phc Corporation | 2024-03-20 |
| Access hsTnI (K222881) | Beckman Coulter, Inc. | 2023-12-18 |
| Access hsTnI (K230648) | Beckman Coulter, Inc. | 2023-12-04 |
| Alinity i STAT High Sensitivity Troponin-I (K230994) | Abbott Laboratories Diagnostics Division | 2023-05-04 |
| Alinity i STAT High Sensitivity Troponin-I (K202525) | Abbott Laboratories Diagnostics Division | 2022-05-19 |
| Elecsys Troponin T Gen 5 (K201441) | Roche Diagnostics | 2021-09-21 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Elecsys Troponin I Immunoassay For the in-vitro quantitative determination of cardiac trop recall (Z-1387-2012) | Roche Diagnostics Operations, Inc. | 2012-04-11 |
| Elecsys Troponin I STAT Immunoassay For the in-vitro quantitative determination of cardiac recall (Z-1388-2012) | Roche Diagnostics Operations, Inc. | 2012-04-11 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S010) | Roche Diagnostics | 2025-05-22 |
| Elecsys Anti-HBe (P190005/S007) | Roche Diagnostics | 2025-05-22 |
| Elecsys Anti-HBe (P190005/S006) | Roche Diagnostics | 2024-10-03 |
| Elecsys Anti-HBs / Elecsys HBs II (P190034/S009) | Roche Diagnostics | 2024-10-03 |
| Elecsys Anti-HBs II (P190034/S008) | Roche Diagnostics | 2024-08-29 |
| Elecsys Anti-HBe (P190005/S005) | Roche Diagnostics | 2024-08-29 |
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S007) | Roche Diagnostics | 2024-07-23 |
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S005) | Roche Diagnostics | 2024-05-01 |