Cleared Traditional

VERIGENE CYP2C19 NUCLEIC ACID TES (2C19)

K120466 · Nanosphere, Inc. · Toxicology

Nov 2012

Decision

265d

Days

Class 2

Risk

About This 510(k) Submission

K120466 is an FDA 510(k) clearance for the VERIGENE CYP2C19 NUCLEIC ACID TES (2C19), a Drug Metabolizing Enzyme Genotyping Systems (Class II — Special Controls, product code NTI), submitted by Nanosphere, Inc. (Northbrook, US). The FDA issued a Cleared decision on November 6, 2012, 265 days after receiving the submission on February 15, 2012. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3360.

Submission Details

510(k) Number	K120466 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 15, 2012
Decision Date	November 06, 2012
Days to Decision	265 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF

Device Classification

Product Code	NTI — Drug Metabolizing Enzyme Genotyping Systems
Device Class	Class II — 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.