Cleared Traditional

K021609 - RDI HS CRP KIT

K021609 is an FDA 510(k) clearance for RDI HS CRP KIT, manufactured by Reference Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code DCK cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K021609 · Reference Diagnostics, Inc. · Chemistry device
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Jun 2002
Decision
42d
Days
Class 2
Risk

K021609 is an FDA 510(k) clearance for the RDI HS CRP KIT. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Reference Diagnostics, Inc. (Bedford, US). The FDA issued a Cleared decision on June 27, 2002 after a review of 42 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K021609

510(k) Number K021609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2002
Decision Date June 27, 2002
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 88d · This submission: 42d
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 Chemistry devices follow this clearance model.

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

All 116
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K021609.
ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257
K022176 · Orion Diagnostica, Div. Orion Corp. · Dec 2002
K-ASSAY HS-CRP CONTROLS
K022486 · Kamiya Biomedical Co. · Aug 2002
RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM
K021194 · Hemagen Diagnostics, Inc. · Jul 2002
NYCOCARD CRP
K013787 · Primus Corp. · May 2002
NYCOCARD CRP CONTROL
K014084 · Primus Corp. · Jan 2002
BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119
K003851 · Biocheck, Inc. · Jul 2001
K021609 · RDI HS CRP KIT
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