Cleared Abbreviated

SPARTAN RX CYP2C19 TEST SYSTEM

K123891 · Spartan Bioscience, Inc. · Toxicology

Aug 2013

Decision

237d

Days

Class 2

Risk

About This 510(k) Submission

K123891 is an FDA 510(k) clearance for the SPARTAN RX CYP2C19 TEST SYSTEM, a Drug Metabolizing Enzyme Genotyping Systems (Class II — Special Controls, product code NTI), submitted by Spartan Bioscience, Inc. (Redwood Shores, US). The FDA issued a Cleared decision on August 12, 2013, 237 days after receiving the submission on December 18, 2012. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3360.

Submission Details

510(k) Number	K123891 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 18, 2012
Decision Date	August 12, 2013
Days to Decision	237 days
Submission Type	Abbreviated
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.