Cleared Traditional

K062368 - WAKO LBA DCP TEST SYSTEM, MODEL 993-05301 (FDA 510(k) Clearance)

Also includes:
DCP CONTROL SET, MODEL 995-0551 DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K062368 · Wako Chemicals USA, Inc. · Immunology device
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Jan 2007
Decision
170d
Days
Class 2
Risk

K062368 is an FDA 510(k) clearance for the WAKO LBA DCP TEST SYSTEM, MODEL 993-05301. Classified as Des-gamma-carboxy-prothrombin (dcp), Risk Assessment, Hepatocellular Carcinoma (product code OAU), Class II - Special Controls.

Submitted by Wako Chemicals USA, Inc. (Richmond, US). The FDA issued a Cleared decision on January 31, 2007 after a review of 170 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.6030 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Wako Chemicals USA, Inc. devices

Submission Details

510(k) Number K062368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 104d · This submission: 170d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OAU Des-gamma-carboxy-prothrombin (dcp), Risk Assessment, Hepatocellular Carcinoma
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.