| Device Type ID | 446 |
| Device Name | Calibrator, Multi-analyte Mixture |
| Regulation Description | Calibrator. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 862.1150 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | JIX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 446 |
| Device | Calibrator, Multi-analyte Mixture |
| Product Code | JIX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Calibrator. |
| CFR Regulation Number | 862.1150 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BECKMAN COULTER, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ELITECHGROUP | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ORTHO-CLINICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ORTHO-CLINICAL DIAGNOSTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SIEMENS HEALTHCARE DIAGNOSTICS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Low Test Results | 8 |
Adverse Event Without Identified Device Or Use Problem | 4 |
High Test Results | 2 |
Incorrect Or Inadequate Test Results | 2 |
Mechanical Problem | 1 |
Calibrator | 1 |
Tube | 1 |
| Total Device Problems | 19 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | AMS Diagnostics, LLC | III | Jul-13-2017 |
| 2 | Abbott Laboratories Inc. | II | Jun-25-2015 |
| 3 | Beckman Coulter Inc | II | Jul-13-2017 |
| 4 | Beckman Coulter Inc. | II | Feb-13-2018 |
| 5 | ELITech Clinical Systems SAS | II | Aug-01-2018 |
| 6 | Horiba Instruments, Inc Dba Horiba Medical | II | Mar-05-2014 |
| 7 | Kamiya Biomedical Company, LLC | II | Oct-20-2017 |
| 8 | Ortho-Clinical Diagnostics | III | Sep-14-2018 |
| 9 | Ortho-Clinical Diagnostics | II | Aug-13-2014 |
| 10 | Ortho-Clinical Diagnostics | II | Feb-25-2014 |
| 11 | Randox Laboratories Ltd. | II | Dec-21-2018 |
| 12 | Siemens Healthcare Diagnostics | II | Sep-15-2014 |
| 13 | Siemens Healthcare Diagnostics, Inc | II | Mar-08-2016 |
| 14 | Siemens Healthcare Diagnostics, Inc | II | Dec-16-2014 |
| 15 | Siemens Healthcare Diagnostics, Inc. | II | Mar-26-2018 |
| 16 | Siemens Healthcare Diagnostics, Inc. | III | Feb-16-2017 |
| 17 | Siemens Healthcare Diagnostics, Inc. | II | Nov-22-2016 |
| 18 | Siemens Healthcare Diagnostics, Inc. | II | Mar-25-2015 |
| 19 | Siemens Healthcare Diagnostics, Inc. | II | Sep-30-2014 |
| 20 | Siemens Healthcare Diagnostics, Inc. | II | Feb-24-2014 |
| 21 | Tosoh Bioscience Inc | III | Aug-15-2018 |