510(k) K043576

ROCHE AMPLICHIP CYP450 TEST by Roche Molecular Systems, Inc. — Product Code NTI

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 10, 2005
Date Received: December 27, 2004
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Drug Metabolizing Enzyme Genotyping Systems
Device Class: Class II
Regulation Number: 862.3360
Review Panel: TX
Submission Type

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.

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