Cleared Traditional

INVADER UGT1A1 MOLECULAR ASSAY

K051824 · Third Wave Technologies, Inc. · Chemistry

Aug 2005

Decision

44d

Days

Class 2

Risk

About This 510(k) Submission

K051824 is an FDA 510(k) clearance for the INVADER UGT1A1 MOLECULAR ASSAY, a Drug Metabolizing Enzyme Genotyping Systems (Class II — Special Controls, product code NTI), submitted by Third Wave Technologies, Inc. (Madison, US). The FDA issued a Cleared decision on August 18, 2005, 44 days after receiving the submission on July 5, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3360.

Submission Details

510(k) Number	K051824 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 05, 2005
Decision Date	August 18, 2005
Days to Decision	44 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
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.