| Device Type ID | 505 |
| Device Name | Radioimmunoassay, Thyroid-stimulating Hormone |
| Regulation Description | Thyroid Stimulating Hormone 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 | 862.1690 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | JLW |
| 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 | 505 |
| Device | Radioimmunoassay, Thyroid-stimulating Hormone |
| Product Code | JLW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Thyroid Stimulating Hormone Test System. |
| CFR Regulation Number | 862.1690 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BECKMAN COULTER | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BECKMAN COULTER, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BODITECH MED INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NANOEN TEK USA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCHE DIAGNOSTICS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCHE DIAGNOSTICS OPERATIONS, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO.,LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SIEMENS | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SIEMENS HEALTHCARE DIAGNOSTICS INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SYSMEX | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SYSMEX CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Low Test Results | 251 |
High Test Results | 227 |
Incorrect Or Inadequate Test Results | 117 |
Adverse Event Without Identified Device Or Use Problem | 27 |
Non Reproducible Results | 14 |
Unable To Obtain Readings | 11 |
Device Damaged Prior To Use | 11 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 5 |
Cell | 4 |
Tube | 3 |
Probe | 3 |
High Readings | 3 |
No Apparent Adverse Event | 2 |
Appropriate Term/Code Not Available | 2 |
Mechanical Problem | 2 |
Insufficient Information | 1 |
Clamp | 1 |
Device Issue | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Low Readings | 1 |
False Positive Result | 1 |
Device Operational Issue | 1 |
Device Ingredient Or Reagent | 1 |
| Total Device Problems | 690 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Abbott Ireland Diagnostics Division | II | Dec-22-2018 |
| 2 | Clinical Diagnostic Systems | III | Apr-10-2018 |
| 3 | Nichols Institute Diagnostics | II | Jun-25-2015 |
| 4 | ORTHO-CLINICAL DIAGNOSTICS | III | Aug-17-2016 |
| 5 | Ortho Clinical Diagnostics Inc | II | Oct-03-2018 |
| 6 | Ortho-Clinical Diagnostics | II | Oct-05-2018 |
| 7 | Siemens Healthcare Diagnostics, Inc | II | May-23-2014 |
| 8 | Siemens Healthcare Diagnostics, Inc. | II | Jun-01-2018 |
| 9 | Siemens Healthcare Diagnostics, Inc. | II | May-04-2018 |
| 10 | Siemens Healthcare Diagnostics, Inc. | II | May-05-2017 |
| 11 | Siemens Healthcare Diagnostics, Inc. | II | Oct-12-2016 |
| 12 | Siemens Healthcare Diagnostics, Inc. | II | Jul-21-2016 |
| 13 | Siemens Healthcare Diagnostics, Inc. | II | Jun-04-2015 |
| 14 | Tosoh Bioscience Inc | II | Jun-05-2018 |