Not Cleared Direct

DEN190056 - ADVIA Centaur Enhanced Liver Fibrosis (ELF) (FDA 510(k) Clearance)

Class II Chemistry device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN190056 · Siemens Healthcare Diagnostics, Inc. · Chemistry device
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Aug 2021
Decision
603d
Days
Class 2
Risk

DEN190056 is an FDA 510(k) submission (not cleared) for the ADVIA Centaur Enhanced Liver Fibrosis (ELF). Classified as Prognostic Test For Assessment Of Liver Related Disease Progression (product code QQB), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Not Cleared (DENG) decision on August 20, 2021 after a review of 603 days.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1622 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 603 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Siemens Healthcare Diagnostics, Inc. devices

Submission Details

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 -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
515d slower than avg
Panel avg: 88d · This submission: 603d
Pathway characteristics

Device Classification

Product Code QQB Prognostic Test For Assessment Of Liver Related Disease Progression
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.