DEN190056 is an FDA 510(k) submission for the ADVIA Centaur Enhanced Liver Fibrosis (ELF). This device is classified as a Prognostic Test For Assessment Of Liver Related Disease Progression (Class II - Special Controls, product code QQB).
Submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Not Cleared (DENG) decision on August 20, 2021.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1622. 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..
| 510(k) Number | DEN190056 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | December 26, 2019 |
| Decision Date | August 20, 2021 |
| Days to Decision | 603 days |
| Submission Type | Direct |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | QQB — Prognostic Test For Assessment Of Liver Related Disease Progression |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1622 |
| 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. |