Cleared Traditional

K013359 - LP(A)-LATEX SEIKEN ASSAY KIT

K013359 is an FDA 510(k) clearance for LP(A)-LATEX SEIKEN ASSAY KIT, manufactured by Denka Seiken'S. The device is a Class 2 Chemistry device with product code DFC cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K013359 · Denka Seiken'S · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
149d
Days
Class 2
Risk

K013359 is an FDA 510(k) clearance for the LP(A)-LATEX SEIKEN ASSAY KIT. Classified as Lipoprotein, Low-density, Antigen, Antiserum, Control (product code DFC), Class II - Special Controls.

Submitted by Denka Seiken'S (Tokyo, JP). The FDA issued a Cleared decision on March 8, 2002 after a review of 149 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5600 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Denka Seiken'S devices

FDA 510(k) Submission Details - K013359

510(k) Number K013359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2001
Decision Date March 08, 2002
Days to Decision 149 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 88d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DFC Device Classification - Class 2, Special Controls

Product Code DFC Lipoprotein, Low-density, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5600
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 Chemistry devices follow this clearance model.

Regulatory Peers - DFC Lipoprotein, Low-density, Antigen, Antiserum, Control

All 38
Devices cleared under the same product code (DFC) and FDA review panel - the closest regulatory comparables to K013359.
QUANTIA LA(A)
K050487 · Biokit, S.A. · Apr 2005
K-ASSAY LP(A) CONTROLS
K023853 · Kamiya Biomedical Co. · Dec 2002
K-ASSAY LP(A) ASSAY
K021660 · Kamiya Biomedical Co. · Jul 2002
N LATEX LP(A)
K013128 · Dade Behring, Inc. · Jan 2002
TINA-QUANT APOLIPOPROTEIN B VER.2
K013206 · Roche Diagnostics Corp. · Nov 2001
TINA-QUANT APOLIPOPROTEIN B VER.2
K013207 · Roche Diagnostics Corp. · Nov 2001