QQB — Prognostic Test For Assessment Of Liver Related Disease Progression Class II
FDA product code QQB covers "Prognostic Test For Assessment Of Liver Related Disease Progression", a Class II medical device regulated under 21 CFR 862.1622. Submissions are reviewed by the Clinical Chemistry panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QQB
- Device Class
- Class II
- Regulation Number
- 862.1622
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN190056 | siemens healthcare diagnostics | ADVIA Centaur Enhanced Liver Fibrosis (ELF) | August 20, 2021 |