510(k) DEN190056
DEN190056 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics, Inc. for the device "ADVIA Centaur Enhanced Liver Fibrosis (ELF)". The FDA issued a decision of De Novo Granted on August 20, 2021. The device falls under product code QQB (Prognostic Test For Assessment Of Liver Related Disease Progression), a Class II device regulated under 21 CFR 862.1622. Siemens Healthcare Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- August 20, 2021
- Date Received
- December 26, 2019
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prognostic Test For Assessment Of Liver Related Disease Progression
- Device Class
- Class II
- Regulation Number
- 862.1622
- Review Panel
- CH
- Submission Type
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.