Cleared Special

K002558 - K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE

K002558 is an FDA 510(k) clearance for K-ASSAY HIGH SENSITIVE CRP(2) FOR THE B..., manufactured by Kamiya Biomedical Co.. The device is a Class 2 Immunology device with product code DCK cleared through the Special 510(k) pathway after a 72-day FDA review.

K002558 · Kamiya Biomedical Co. · Immunology device
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Oct 2000
Decision
72d
Days
Class 2
Risk

K002558 is an FDA 510(k) clearance for the K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Kamiya Biomedical Co. (Seattle, US). The FDA issued a Cleared decision on October 25, 2000 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5270 - the FDA immunology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K002558

510(k) Number K002558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2000
Decision Date October 25, 2000
Days to Decision 72 days
Submission Type Special
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 105d · This submission: 72d
Pathway characteristics
Modification to existing cleared device.

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 119
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K002558.
SYNCHRON LX SYSTEMS HIGH SENSITIVITY C-REACTIVE PROTIEN (CRPH) REAGENT
K010597 · Beckman Coulter, Inc. · May 2001
K-ASSAY HS-CRP CONTROLS
K011079 · Kamiya Biomedical Co. · May 2001
IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT
K010236 · Beckman Coulter, Inc. · Apr 2001
C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET
K002651 · Pointe Scientific, Inc., · Oct 2000
C-REACTIVE PROTEIN ANTISERUM KIT
K001636 · The Binding Site, Ltd. · Aug 2000
RANDOX C-REACTIVE PROTEIN
K001009 · Randox Laboratories, Ltd. · Aug 2000
K002558 · K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE
Download PDF Kamiya Biomedical Co.