ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM
FDA 510(k) clearance K121214 · decided 2013-06-14
Clearance details
- K-number
- K121214
- Device name
- ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM
- Applicant
- Beckman Coulter, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-04-23
- Decision date
- 2013-06-14
- Days to decision
- 417 days
- Clearance type
- Traditional
- Product code
- MMI
- Device class
- 2
- Regulation number
- 862.1215
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Chaska, MN, US
- Third-party review
- No
- Expedited review
- No
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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 |
|---|---|---|
| Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, recall (Z-0889-2026) | Beckman Coulter, Inc. | 2025-12-09 |
| Access 2 Immunoassay Analyzer, Catalog Number 81600N recall (Z-1386-2025) | Beckman Coulter, Inc. | 2025-03-17 |
| Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitati recall (Z-0727-2025) | Beckman Coulter, Inc. | 2024-12-20 |
| Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immuno recall (Z-1257-2023) | Beckman Coulter, Inc. | 2023-03-15 |
| Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Use Part No. B1 recall (Z-0175-2015) | Beckman Coulter Inc. | 2014-11-06 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Access AFP (on DxI 9000 Analyzer) (P980041/S051) | Beckman Coulter, Inc. | 2025-11-03 |
| Access HBsAg, Access HBsAg Confirmatory, Access HBsAg Calibrator, Access HBsAg QC (P230015) | Beckman Coulter, Inc. | 2025-10-17 |
| Access Hybritech p2PSA (P090026/S032) | Beckman Coulter, Inc. | 2025-06-16 |
| Access Hybritech free PSA (P970038/S046) | Beckman Coulter, Inc. | 2025-05-15 |
| Access Hybritech PSA (P850048/S060) | Beckman Coulter, Inc. | 2024-09-04 |
| Access Hybritech PSA reagent pack (P850048/S059) | Beckman Coulter, Inc. | 2023-05-25 |
| Access AFP Reagents on the Access Immunoassay Systems (P980041/S050) | Beckman Coulter, Inc. | 2022-12-16 |
| Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S057) | Beckman Coulter, Inc. | 2022-12-16 |