Not Cleared Direct

Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5 (DEN150057) - FDA 510(k) Clearance

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

DEN150057 · Roche Diagnostics · Chemistry device
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Dec 2016
Decision
376d
Days
Class 2
Risk

DEN150057 is an FDA 510(k) submission (not cleared) for the Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5. Classified as Anti-müllerian Hormone Test System (product code PQO), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Not Cleared (DENG) decision on December 19, 2016 after a review of 376 days.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1092 - 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 376 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.

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Submission Details

510(k) Number DEN150057 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 09, 2015
Decision Date December 19, 2016
Days to Decision 376 days
Submission Type Direct
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
288d slower than avg
Panel avg: 88d · This submission: 376d
Pathway characteristics

Device Classification

Product Code PQO Anti-müllerian Hormone Test System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1092
Definition An Anti-müllerian Hormone Test System Is An In Vitro Diagnostic Device Intended To Measure Anti-müllerian Hormone In Human Serum And Plasma. The Test Is Intended To Be Used As An Aid For Assessing Ovarian Reserve In Women.
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.