| Device Type ID | 251 |
| Device Name | Radioimmunoassay, Total Triiodothyronine |
| Regulation Description | Total Triiodothyronine Test System. |
| 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 | 862.1710 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | CDP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 251 |
| Device | Radioimmunoassay, Total Triiodothyronine |
| Product Code | CDP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Total Triiodothyronine Test System. |
| CFR Regulation Number | 862.1710 [🔎] |
| Device Problems | |
|---|---|
High Test Results | 375 |
Low Test Results | 144 |
Incorrect Or Inadequate Test Results | 141 |
Low Readings | 115 |
Non Reproducible Results | 17 |
Adverse Event Without Identified Device Or Use Problem | 13 |
Device Ingredient Or Reagent Problem | 9 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 7 |
Insufficient Information | 4 |
High Readings | 3 |
Component Missing | 3 |
Device Ingredient Or Reagent | 1 |
Probe | 1 |
Unable To Obtain Readings | 1 |
Device Damaged Prior To Use | 1 |
Device Subassembly | 1 |
Cell | 1 |
Tube | 1 |
| Total Device Problems | 838 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Abbott Ireland Diagnostics Division | II | Feb-04-2019 |
| 2 | Abbott Ireland Diagnostics Division | II | Dec-03-2014 |
| 3 | Beckman Coulter Inc. | II | Jun-28-2017 |
| 4 | Beckman Coulter Inc. | II | Jun-30-2016 |
| 5 | Beckman Coulter Inc. | II | Oct-07-2015 |
| 6 | ORTHO-CLINICAL DIAGNOSTICS | III | Jun-04-2015 |
| 7 | Siemens Healthcare Diagnostics | II | Jan-30-2014 |
| 8 | Siemens Healthcare Diagnostics, Inc | II | Feb-26-2018 |
| 9 | Tosoh Bioscience Inc | II | Dec-22-2018 |
| 10 | Tosoh Bioscience Inc | II | Jun-05-2018 |