| Device Type ID | 258 |
| Device Name | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Regulation Description | Testosterone 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 | 862.1680 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | CDZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 258 |
| Device | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Product Code | CDZ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Testosterone Test System. |
| CFR Regulation Number | 862.1680 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ABBOTT | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ABBOTT LABORATORIES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOKIT, S.A. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
QUALIGEN, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SIEMENS | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SIEMENS HEALTHCARE DIAGNOSTICS INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TOSOH CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
High Test Results | 16 |
Adverse Event Without Identified Device Or Use Problem | 11 |
Low Test Results | 8 |
Mechanical Problem | 6 |
Incorrect Or Inadequate Test Results | 4 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 3 |
Probe | 2 |
Device Subassembly | 2 |
Cell | 1 |
Pump | 1 |
Device Issue | 1 |
Mixer | 1 |
Nozzle | 1 |
PC (Printed Circuit) Board | 1 |
False Positive Result | 1 |
Washer | 1 |
| Total Device Problems | 60 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Abbott Laboratories | II | May-03-2017 |
| 2 | Siemens Healthcare Diagnostics, Inc. | II | Jul-13-2018 |
| 3 | Siemens Healthcare Diagnostics, Inc. | II | Apr-19-2017 |
| 4 | Tosoh Bioscience Inc | II | Dec-22-2018 |
| 5 | Tosoh Bioscience Inc | II | Jun-05-2018 |
| 6 | bioMerieux, Inc. | II | Jun-29-2017 |