Definition: For The Quantitative Measurement Of Uric Acid In Home Use Settings By Patients Diagnosed With Gout. This Device Is For Prescription Use Only.
| Device Type ID | 674 |
| Device Name | Uric Acid Test System For At Home Prescription Use |
| Physical State | Handheld Meter |
| Technical Method | Quantitative Enzymatic Activity Assay |
| Target Area | Capillary Whole Blood, In Vitro Diagnostic Use. |
| Regulation Description | Uric Acid 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 | 862.1775 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | PTC |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 674 |
| Device | Uric Acid Test System For At Home Prescription Use |
| Product Code | PTC |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Uric Acid Test System. |
| CFR Regulation Number | 862.1775 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
NOVA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NOVA BIOMEDICAL CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TAIDOC TECHNOLOGY CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |