Des-gamma-carboxy-prothrombin (dcp), Risk Assessment, Hepatocellular Carcinoma
Device Code: 3078
Product Code(s):
OAU Definition: The Test Is Intended To Quantitatively Measure Dcp In Human Serum And Use As An Aid In The Risk Assessment Of Patients With Chronic Liver Disease For Progression To Hepatocellular Carcinoma (hcc) In Conjunction With Other Laboratory Findings, Imaging
Device Classification Information
| Device Type ID | 3078 |
| Device Name | Des-gamma-carboxy-prothrombin (dcp), Risk Assessment, Hepatocellular Carcinoma |
| Physical State | An Assay Kit Containing Specific Antibodies, Substrates And Reaction Columns |
| Technical Method | Immunochemical Liquid-phase Binding Assay |
| Target Area | Peripheral Blood |
| Regulation Description | AFP-L3% Immunological Test System. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| CFR Regulation Number | 866.6030 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OAU |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 3078 |
| Device | Des-gamma-carboxy-prothrombin (dcp), Risk Assessment, Hepatocellular Carcinoma |
| Product Code | OAU |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | AFP-L3% Immunological Test System. |
| CFR Regulation Number | 866.6030 [🔎] |
TPLC Last Update: 2019-04-02 20:23:31