Not Cleared Post-NSE

AMPLICHIP CYP450 TEST, MODEL 04381866190 (DEN040011) - FDA 510(k) Clearance

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

DEN040011 · Roche Molecular Systems, Inc. · Chemistry device
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Dec 2004
Decision
3d
Days
Class 2
Risk

DEN040011 is an FDA 510(k) submission (not cleared) for the AMPLICHIP CYP450 TEST, MODEL 04381866190. Classified as Drug Metabolizing Enzyme Genotyping Systems (product code NTI), Class II - Special Controls.

Submitted by Roche Molecular Systems, Inc. (Pleasanton, US). The FDA issued a Not Cleared (DENG) decision on December 23, 2004 after a review of 3 days.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3360 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Chemistry review framework.

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Submission Details

510(k) Number DEN040011 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 20, 2004
Decision Date December 23, 2004
Days to Decision 3 days
Submission Type Post-NSE
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 88d · This submission: 3d
Pathway characteristics

Device Classification

Product Code NTI Drug Metabolizing Enzyme Genotyping Systems
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3360
Definition Intended To Identify The Presence Or Absence Of Human Genotypic Markers Encoding Drug Metaboizing Enzymes Using Dna Originating From Clinical Samples. This Type Of Assay Can Be Used As An Aid Determining Treatment Choice And Individualizing Treatment Dose For Therapeutics That Are Metabolized Primarily By The Specific Enzyme Tested By The System.
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.