| Device Type ID | 376 |
| Device Name | System, Test, Human Chorionic Gonadotropin |
| Regulation Description | Human Chorionic Gonadotropin (HCG) 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 | 862.1155 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DHA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 376 |
| Device | System, Test, Human Chorionic Gonadotropin |
| Product Code | DHA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Human Chorionic Gonadotropin (HCG) Test System. |
| CFR Regulation Number | 862.1155 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ABBOTT | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ABBOTT LABORATORIES | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
DIAZYME LABORATORIES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Low Test Results | 156 |
High Test Results | 133 |
False Positive Result | 87 |
Adverse Event Without Identified Device Or Use Problem | 51 |
Mechanical Problem | 32 |
False Negative Result | 14 |
Probe | 12 |
Incorrect Or Inadequate Test Results | 12 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 5 |
Tube | 4 |
Device Issue | 3 |
Cell | 3 |
Mixer | 3 |
Seal | 2 |
Screw | 1 |
Use Of Device Problem | 1 |
High Readings | 1 |
Device Operates Differently Than Expected | 1 |
Washer | 1 |
PC (Printed Circuit) Board | 1 |
Cover | 1 |
Device Subassembly | 1 |
Device Handling Problem | 1 |
Brush | 1 |
Clip | 1 |
Ring | 1 |
Spring | 1 |
Adapter (Adaptor) | 1 |
Missing Value Reason | 1 |
Unable To Obtain Readings | 1 |
Device Damaged Prior To Use | 1 |
| Total Device Problems | 534 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Abbott Ireland Diagnostics Division | II | Dec-22-2018 |
| 2 | Ortho-Clinical Diagnostics | II | May-20-2016 |
| 3 | Siemens Healthcare Diagnostics Inc | II | Jan-07-2016 |
| 4 | Tosoh Bioscience Inc | II | Jun-05-2018 |