Cleared Special

OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT (K002918) - FDA 510(k) Clearance

Class II Immunology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K002918 · Olympus America, Inc. · Immunology device
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Oct 2000
Decision
36d
Days
Class 2
Risk

K002918 is an FDA 510(k) clearance for the OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT. Classified as System, Test, C-reactive Protein (product code DCN), Class II - Special Controls.

Submitted by Olympus America, Inc. (Irving, US). The FDA issued a Cleared decision on October 25, 2000 after a review of 36 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.

View all Olympus America, Inc. devices

Submission Details

510(k) Number K002918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2000
Decision Date October 25, 2000
Days to Decision 36 days
Submission Type Special
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 104d · This submission: 36d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 Immunology devices follow this clearance model.

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

All 20
Devices cleared under the same product code (DCN) and FDA review panel - the closest regulatory comparables to K002918.
CRP HS TEST SYSTEM
K003400 · Roche Diagnostics Corp. · May 2001
RCRP FLEX REAGENT CARTRIDGE
K003419 · Dade Behring, Inc. · Feb 2001
IMMULITE HIGH SENSITIVITY CRP, IMMULITE 2000 HIGH SENSITIVITY CRP
K003372 · Diagnostic Products Corp. · Dec 2000
CRP
K991372 · Abbott Laboratories · Jun 1999
REVISED C-REACTIVE PROTEIN (RCRP) FLEX REAGENT CARTRIDGE
K990825 · Dade Behring, Inc. · Apr 1999
SYNCHRON C-REACTIVE PROTEIN REAGENT
K910535 · Beckman Instruments, Inc. · Apr 1991