Cleared Traditional

K011958 - CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT

K011958 is an FDA 510(k) clearance for CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ..., manufactured by Denka Seiken'S. The device is a Class 2 Chemistry device with product code DCN cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K011958 · Denka Seiken'S · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
165d
Days
Class 2
Risk

K011958 is an FDA 510(k) clearance for the CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT. Classified as System, Test, C-reactive Protein (product code DCN), Class II - Special Controls.

Submitted by Denka Seiken'S (Tokyo, JP). The FDA issued a Cleared decision on December 4, 2001 after a review of 165 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5270 - 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 - K011958

510(k) Number K011958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2001
Decision Date December 04, 2001
Days to Decision 165 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
77d slower than avg
Panel avg: 88d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DCN Device Classification - Class 2, Special Controls

Product Code DCN System, Test, C-reactive Protein
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 Chemistry devices follow this clearance model.

Regulatory Peers - DCN System, Test, C-reactive Protein

All 47
Devices cleared under the same product code (DCN) and FDA review panel - the closest regulatory comparables to K011958.
C-REACTIVE PROTEIN (CRP)
K030899 · Abbott Laboratories · Jul 2003
SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT
K021572 · Beckman Coulter, Inc. · Jul 2002
BAYER ADVIA IMS SYSTEM
K012337 · Bayer Corp. · Dec 2001
CRP HS TEST SYSTEM
K003400 · Roche Diagnostics Corp. · May 2001
RCRP FLEX REAGENT CARTRIDGE
K003419 · Dade Behring, Inc. · Feb 2001
WAKO CRP-UL, CRP-UL CALIBRATOR SET
K003342 · Wako Chemicals USA, Inc. · Jan 2001