| Device Type ID | 444 |
| Device Name | Calibrator, Secondary |
| 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 | JIT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 444 |
| Device | Calibrator, Secondary |
| Product Code | JIT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Calibrator. |
| CFR Regulation Number | 862.1150 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ABBOTT | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ABBOTT LABORATORIES | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BECKMAN COULTER | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BECKMAN COULTER, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
DIAMOND DIAGNOSTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FUJIREBIO DIAGNOSTICS, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MITSUBISHI CHEMICAL MEDIENCE CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RANDOX LABORATORIES, LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCHE DIAGNOSTICS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
ROCHE DIAGNOSTICS OPERATIONS, INC | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
SEKISUI DIAGNOSTICS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SENTINEL CH. SPA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SIEMENS HEALTHCARE DIAGNOSTICS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TOSOH CORP. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
| Device Problems | |
|---|---|
Low Test Results | 6 |
Calibration Problem | 3 |
Adverse Event Without Identified Device Or Use Problem | 3 |
High Test Results | 2 |
Use Of Device Problem | 1 |
Device Ingredient Or Reagent Problem | 1 |
Calibrator | 1 |
Device Issue | 1 |
| Total Device Problems | 18 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Abbott Laboratories | II | May-29-2014 |
| 2 | Medica Corporation | II | Mar-28-2018 |
| 3 | Ortho-Clinical Diagnostics | III | Feb-09-2017 |
| 4 | Ortho-Clinical Diagnostics | III | Sep-15-2016 |
| 5 | Ortho-Clinical Diagnostics | III | Nov-02-2015 |
| 6 | Ortho-Clinical Diagnostics | II | Jun-16-2014 |
| 7 | Ortho-Clinical Diagnostics | III | Mar-12-2014 |
| 8 | Randox Laboratories Ltd. | II | Mar-15-2019 |
| 9 | Siemens Healthcare Diagnostics, Inc | II | Apr-19-2017 |
| 10 | Siemens Healthcare Diagnostics, Inc. | II | Jan-29-2019 |
| 11 | Siemens Healthcare Diagnostics, Inc. | III | Feb-16-2017 |
| 12 | Siemens Healthcare Diagnostics, Inc. | II | Jan-08-2015 |
| 13 | Siemens Healthcare Diagnostics, Inc. | II | Oct-06-2014 |
| 14 | Siemens Healthcare Diagnostics, Inc. | II | Jun-26-2014 |
| 15 | Tosoh Bioscience Inc | II | May-14-2018 |
| 16 | Tosoh Bioscience, Inc. | III | Jul-25-2016 |