Cleared Traditional

K011079 - K-ASSAY HS-CRP CONTROLS

K011079 is the FDA 510(k) clearance for K-ASSAY HS-CRP CONTROLS by Kamiya Biomedical Co.. It is a Class 2 Immunology device (product code DCK) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K011079 · Kamiya Biomedical Co. · Immunology device
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May 2001
Decision
37d
Days
Class 2
Risk

K011079 is an FDA 510(k) clearance for the K-ASSAY HS-CRP CONTROLS. 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 May 16, 2001 after a review of 37 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kamiya Biomedical Co. devices

Submission Details

510(k) Number K011079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2001
Decision Date May 16, 2001
Days to Decision 37 days
Submission Type Traditional
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
67d faster than avg
Panel avg: 104d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 75
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K011079.
K-ASSAY HS-CRP CONTROLS
K022486 · Kamiya Biomedical Co. · Aug 2002
RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM
K021194 · Hemagen Diagnostics, Inc. · Jul 2002
SYNCHRON LX SYSTEMS HIGH SENSITIVITY C-REACTIVE PROTIEN (CRPH) REAGENT
K010597 · Beckman Coulter, Inc. · May 2001
IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT
K010236 · Beckman Coulter, Inc. · Apr 2001
K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE
K002558 · Kamiya Biomedical Co. · Oct 2000
C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET
K002651 · Pointe Scientific, Inc., · Oct 2000