| Device Type ID | 3014 |
| Device Name | System, Test, Thyroid Autoantibody |
| Regulation Description | Thyroid Autoantibody Immunological Test System. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.5870 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | JZO |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 3014 |
| Device | System, Test, Thyroid Autoantibody |
| Product Code | JZO |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Thyroid Autoantibody Immunological Test System. |
| CFR Regulation Number | 866.5870 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
PHADIA AB | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
High Test Results | 46 |
Adverse Event Without Identified Device Or Use Problem | 11 |
Incorrect Or Inadequate Test Results | 11 |
Low Test Results | 5 |
Non Reproducible Results | 4 |
Incorrect Measurement | 2 |
Probe | 2 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Insufficient Information | 1 |
No Apparent Adverse Event | 1 |
Device Ingredient Or Reagent Problem | 1 |
Washer | 1 |
| Total Device Problems | 86 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Tosoh Bioscience, Inc. | III | May-15-2017 |