Cleared Traditional

K030545 - CRP-LATEX (II)X2 SEIKEN ASSAY KIT

K030545 is an FDA 510(k) clearance for CRP-LATEX (II)X2 SEIKEN ASSAY KIT, manufactured by Denka Seiken Co., Ltd.. The device is a Class 2 Immunology device with product code DCK cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K030545 · Denka Seiken Co., Ltd. · Immunology device
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Jun 2003
Decision
102d
Days
Class 2
Risk

K030545 is an FDA 510(k) clearance for the CRP-LATEX (II)X2 SEIKEN ASSAY KIT. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Denka Seiken Co., Ltd. (Gosen City, Niigata, JP). The FDA issued a Cleared decision on June 2, 2003 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5270 - 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 Denka Seiken Co., Ltd. devices

FDA 510(k) Submission Details - K030545

510(k) Number K030545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2003
Decision Date June 02, 2003
Days to Decision 102 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
3d faster than avg
Panel avg: 105d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DCK Device Classification - Class 2, Special Controls

Product Code DCK C-reactive Protein, Antigen, Antiserum, And Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5270
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.

Regulatory Peers - DCK C-reactive Protein, Antigen, Antiserum, And Control

All 106
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K030545.
QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH SENSITIVITY CONTROLS VE CONTROLS 1/2
K032663 · Instrumentation Laboratory CO · Dec 2003
EXTENDED RANGE HS CRP KIT, CAT NO:9200
K030044 · Reference Diagnostics, Inc. · Sep 2003
WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET
K024280 · Wako Chemicals USA, Inc. · Jun 2003
VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 7
K030626 · Ortho-Clinical Diagnostics, Inc. · Mar 2003
K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR
K023828 · Kamiya Biomedical Co. · Feb 2003
HEMOSIL C-REACTIVE PROTEIN - HIGH SENSITIVITY AND HIGH SENSITIVITY CONTROLS
K023269 · Instrumentation Laboratory CO · Dec 2002