Cleared Traditional

K023269 - HEMOSIL C-REACTIVE PROTEIN - HIGH SENSI...

K023269 is the FDA 510(k) clearance for HEMOSIL C-REACTIVE PROTEIN - HIGH SENSI... by Instrumentation Laboratory CO. It is a Class 2 Chemistry device (product code DCK) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K023269 · Instrumentation Laboratory CO · Chemistry device
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Dec 2002
Decision
83d
Days
Class 2
Risk

K023269 is an FDA 510(k) clearance for the HEMOSIL C-REACTIVE PROTEIN - HIGH SENSITIVITY AND HIGH SENSITIVITY CONTROLS. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on December 23, 2002 after a review of 83 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.

View all Instrumentation Laboratory CO devices

Submission Details

510(k) Number K023269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2002
Decision Date December 23, 2002
Days to Decision 83 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 88d · This submission: 83d
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 Chemistry devices follow this clearance model.

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

All 60
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K023269.
QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH SENSITIVITY CONTROLS VE CONTROLS 1/2
K032663 · Instrumentation Laboratory CO · Dec 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
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
C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET
K002651 · Pointe Scientific, Inc., · Oct 2000