Cleared Traditional

OLYMPUS C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC REAGENT (K954537) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K954537 · Olympus America, Inc. · Immunology device
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Feb 1996
Decision
138d
Days
Class 2
Risk

K954537 is an FDA 510(k) clearance for the OLYMPUS C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC REAGENT. Classified as System, Test, C-reactive Protein (product code DCN), Class II - Special Controls.

Submitted by Olympus America, Inc. (Melville, US). The FDA issued a Cleared decision on February 14, 1996 after a review of 138 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Olympus America, Inc. devices

Submission Details

510(k) Number K954537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1995
Decision Date February 14, 1996
Days to Decision 138 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 104d · This submission: 138d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K954537.
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
DU PONT DIMENSION C-REACTIVE PROTEIN METHOD
K883515 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1988
EMIT C-REACTIVE PROTEIN ASSAY
K821413 · Syva Co. · May 1982