| Device |
prognostic test for assessment of liver related disease progression |
| Regulation Description |
Prognostic test for assessment of liver related disease progression. |
| Definition |
prognostic test for assessment of liver related disease progression is intended to measure one or more analytes obtained from human samples as an aid in assessing progression of liver related disease. This device is not intended for diagnosis of any disease, for monitoring the effect of any therapeutic product, for assessing progression to hepatocellular carcinoma, or for assessing disease progression in individuals with viral hepatitis. It is also not intended for the detection of viruses, viral antigens, or antibodies to viruses. |
| Physical State |
The test system may include clinical analyzers, reagents, calibrators, and controls. |
| Technical Method |
Assay to measure analyte(s) that are markers of liver disease progression. |
| Target Area |
The test system is an in vitro diagnostic device that measures human samples. |
| Regulation Medical Specialty |
Clinical Chemistry |
| Review Panel |
Clinical Chemistry |
|---|
| Product Code | QQB |
|---|
| Premarket Review |
Division of Chemistry and Toxicology Devices
(DCTD)
Division of Chemistry and Toxicology Devices
(DCTD)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
862.1622
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
