Cleared Traditional

WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401

K062368 · Wako Chemicals USA, Inc. · Immunology

Jan 2007

Decision

170d

Days

Class 2

Risk

About This 510(k) Submission

K062368 is an FDA 510(k) clearance for the WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401, a Des-gamma-carboxy-prothrombin (dcp), Risk Assessment, Hepatocellular Carcinoma (Class II — Special Controls, product code OAU), submitted by Wako Chemicals USA, Inc. (Richmond, US). The FDA issued a Cleared decision on January 31, 2007, 170 days after receiving the submission on August 14, 2006. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6030.

Submission Details

510(k) Number	K062368 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 14, 2006
Decision Date	January 31, 2007
Days to Decision	170 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF

Device Classification

Product Code	OAU — Des-gamma-carboxy-prothrombin (dcp), Risk Assessment, Hepatocellular Carcinoma
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.6030
Definition	The Test Is Intended To Quantitatively Measure Dcp In Human Serum And Use As An Aid In The Risk Assessment Of Patients With Chronic Liver Disease For Progression To Hepatocellular Carcinoma (hcc) In Conjunction With Other Laboratory Findings, Imaging Studies And Clinical Assessment For Risk Assessment Of Patients With Chronic Liver Disease For Progression To Hepatocellular Carcinoma.