Cleared Traditional

K955042 - CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEM

K955042 is an FDA 510(k) clearance for CHROMALEX C-REACTIVE PROTEIN LATEX TEST..., manufactured by Shared Systems, Inc.. The device is a Class 2 Immunology device with product code DCN cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K955042 · Shared Systems, Inc. · Immunology device
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Dec 1995
Decision
40d
Days
Class 2
Risk

K955042 is an FDA 510(k) clearance for the CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEM. Classified as System, Test, C-reactive Protein (product code DCN), Class II - Special Controls.

Submitted by Shared Systems, Inc. (Martinez, US). The FDA issued a Cleared decision on December 13, 1995 after a review of 40 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. 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 Shared Systems, Inc. devices

FDA 510(k) Submission Details - K955042

510(k) Number K955042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1995
Decision Date December 13, 1995
Days to Decision 40 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
65d faster than avg
Panel avg: 105d · This submission: 40d
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 47
Devices cleared under the same product code (DCN) and FDA review panel - the closest regulatory comparables to K955042.
REVISED C-REACTIVE PROTEIN (RCRP) FLEX REAGENT CARTRIDGE
K990825 · Dade Behring, Inc. · Apr 1999
RAPET CRP
K974429 · Stanbio Laboratory · Feb 1998
OLYMPUS C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC REAGENT
K954537 · Olympus America, Inc. · Feb 1996
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