Cleared Traditional

ROCHE AMPLICHIP CYP450 TEST (K043576) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K043576 · Roche Molecular Systems, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Jan 2005
Decision
14d
Days
Class 2
Risk

K043576 is an FDA 510(k) clearance for the ROCHE AMPLICHIP CYP450 TEST. 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 Cleared decision on January 10, 2005 after a review of 14 days - a notably fast clearance cycle.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Roche Molecular Systems, Inc. devices

Submission Details

510(k) Number K043576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2004
Decision Date January 10, 2005
Days to Decision 14 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 88d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.