| Device Type ID | 590 |
| Device Name | Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine |
| Regulation Description | Total Thyroxine 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 | 862.1700 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KLI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 590 |
| Device | Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine |
| Product Code | KLI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Total Thyroxine Test System. |
| CFR Regulation Number | 862.1700 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ORTHO-CLINICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ORTHO-CLINICAL DIAGNOSTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Incorrect, Inadequate Or Imprecise Result Or Readings | 2 |
High Test Results | 2 |
Incorrect Or Inadequate Test Results | 1 |
| Total Device Problems | 5 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | ORTHO-CLINICAL DIAGNOSTICS | II | Jul-29-2016 |
| 2 | Ortho-Clinical Diagnostics | II | May-21-2014 |
| 3 | Siemens Healthcare Diagnostics, Inc. | II | May-04-2018 |
| 4 | Tosoh Bioscience Inc | II | Jun-05-2018 |