| Device Type ID | 416 |
| Device Name | Visual, Pregnancy Hcg, Prescription Use |
| 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 | JHI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 416 |
| Device | Visual, Pregnancy Hcg, Prescription Use |
| Product Code | JHI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Human Chorionic Gonadotropin (HCG) Test System. |
| CFR Regulation Number | 862.1155 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
JAMES NGUYEN | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
POLYMED THERAPEUTICS, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SIEMENS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SIEMENS HEALTHCARE DIAGNOSTICS INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
False Negative Result | 328 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 82 |
Incorrect Or Inadequate Test Results | 53 |
Adverse Event Without Identified Device Or Use Problem | 37 |
False Positive Result | 8 |
No Apparent Adverse Event | 6 |
High Test Results | 2 |
Insufficient Information | 2 |
Cut In Material | 1 |
Device Issue | 1 |
| Total Device Problems | 520 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ekla Corporation | II | Jul-09-2018 |
| 2 | Tosoh Bioscience Inc | II | Jun-05-2018 |