Cleared Traditional

K954537 - OLYMPUS C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC REAGENT

K954537 is an FDA 510(k) clearance for OLYMPUS C-REACTIVE PROTEIN IMMUNOTURBID..., manufactured by Olympus America, Inc.. The device is a Class 2 Immunology device with product code DCN cleared through the Traditional 510(k) pathway after a 138-day FDA review.

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

FDA 510(k) Submission Details - K954537

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 105d · This submission: 138d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DCN Device Classification - Class 2, Special Controls

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 50
Devices cleared under the same product code (DCN) and FDA review panel - the closest regulatory comparables to K954537.
CRP
K991372 · Abbott Laboratories · Jun 1999
REVISED C-REACTIVE PROTEIN (RCRP) FLEX REAGENT CARTRIDGE
K990825 · Dade Behring, Inc. · Apr 1999
RAPET CRP
K974429 · Stanbio Laboratory · Feb 1998
SPQ CRP CONTROL LEVEL II
K935075 · Incstar Corp. · Jan 1994
EYE SPOT CRP TEST
K932180 · J.S. Medical Assoc. · Aug 1993
SYNCHRON C-REACTIVE PROTEIN REAGENT
K910535 · Beckman Instruments, Inc. · Apr 1991