VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS
FDA 510(k) clearance K031031 · decided 2003-09-29
Clearance details
- K-number
- K031031
- Device name
- VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-04-01
- Decision date
- 2003-09-29
- Days to decision
- 181 days
- Clearance type
- Traditional
- Product code
- MMI
- Device class
- 2
- Regulation number
- 862.1215
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Rochester, NY, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Ortho-Clinical 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 |
|---|---|---|
| VITROS Immunodiagnostic Products Troponin I Reagent Pack, REF/Catalog No. 194 9882. A Trop recall (Z-0820-2007) | Ortho-Clinical Diagnostics | 2007-05-26 |
| Vitros Immunodiagnostic Products TROPONIN I Reagent Packs, (Lot 1110 and 1130 REF #194 988 recall (Z-1053-04) | Ortho-Clinical Diagnostics | 2004-07-20 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VITROS Anti-HBc IgM (P030026/S037) | Ortho-Clinical Diagnostics, Inc. | 2023-01-24 |
| VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator (P090028/S018) | Ortho-Clinical Diagnostics, Inc. | 2023-01-24 |
| VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator (P000014/S036) | Ortho-Clinical Diagnostics, Inc. | 2020-10-22 |
| VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator (P010021/S033) | Ortho-Clinical Diagnostics, Inc. | 2020-08-07 |
| VITROS Anti-HBs (P000014/S035) | Ortho-Clinical Diagnostics, Inc. | 2019-06-19 |
| VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator (P010021/S032) | Ortho-Clinical Diagnostics, Inc. | 2019-06-19 |
| VITROS Anti-HBc IgM (P030026/S036) | Ortho-Clinical Diagnostics, Inc. | 2019-06-19 |
| VITROS HBeAg (P090028/S017) | Ortho-Clinical Diagnostics, Inc. | 2019-06-19 |