| Device Type ID | 260 |
| Device Name | Radioimmunoassay, Free Thyroxine |
| Regulation Description | Free 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) |
| CFR Regulation Number | 862.1695 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | CEC |
| 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 | 260 |
| Device | Radioimmunoassay, Free Thyroxine |
| Product Code | CEC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Free Thyroxine Test System. |
| CFR Regulation Number | 862.1695 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ABBOTT | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ABBOTT LABORATORIES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOMERIEUX SA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NANOENTEK INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCHE DIAGNOSTICS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ROCHE DIAGNOSTICS OPERATIONS, INC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SIEMENS | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SIEMENS HEALTHCARE DIAGNOSTICS INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
High Test Results | 400 |
Incorrect Or Inadequate Test Results | 153 |
Low Test Results | 48 |
Adverse Event Without Identified Device Or Use Problem | 26 |
Non Reproducible Results | 13 |
Calibration Problem | 8 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 8 |
Mechanical Problem | 5 |
Insufficient Information | 3 |
Cell | 3 |
High Readings | 3 |
Tube | 2 |
Device Issue | 2 |
Probe | 2 |
Labelling, Instructions For Use Or Training Problem | 1 |
Human Factors Issue | 1 |
False Negative Result | 1 |
Seal | 1 |
Mixer | 1 |
Incorrect Measurement | 1 |
Low Readings | 1 |
False Positive Result | 1 |
Device Ingredient Or Reagent | 1 |
| Total Device Problems | 685 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Abbott Ireland Diagnostics Division | II | Dec-22-2018 |
| 2 | Beckman Coulter Inc. | II | Jun-28-2017 |
| 3 | Siemens Healthcare Diagnostics, Inc. | II | May-04-2018 |
| 4 | Tosoh Bioscience Inc | II | Jun-05-2018 |