Cleared Traditional

K954447 - C-REACTIVE PROTEIN LATEX KIT

K954447 is the FDA 510(k) clearance for C-REACTIVE PROTEIN LATEX KIT by Randox Laboratories, Ltd.. It is a Class 2 Immunology device (product code DCK) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K954447 · Randox Laboratories, Ltd. · Immunology device
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Dec 1995
Decision
84d
Days
Class 2
Risk

K954447 is an FDA 510(k) clearance for the C-REACTIVE PROTEIN LATEX KIT. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Randox Laboratories, Ltd. (Crumlin, IE). The FDA issued a Cleared decision on December 18, 1995 after a review of 84 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 Randox Laboratories, Ltd. devices

Submission Details

510(k) Number K954447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1995
Decision Date December 18, 1995
Days to Decision 84 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
20d faster than avg
Panel avg: 104d · This submission: 84d
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 Immunology devices follow this clearance model.

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

All 81
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K954447.
N LATEX CRP MONO REAGENT
K962523 · Behring Diagnostics, Inc. · Jul 1996
HEMAGEN CRP 150 KIT (EIA METHOD)
K960324 · Hemagen Diagnostics, Inc. · Mar 1996
WAKO AUTOKIT CRP NEW
K955156 · Wako Chemicals USA, Inc. · Feb 1996
HUMAN C-REACTIVE PROTEIN KIT (MODIFICATION)
K953207 · The Binding Site, Ltd. · Aug 1995
C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC KIT & CRP CALIBRATOR
K953212 · Randox Laboratories, Ltd. · Jul 1995
MAS LIQUID ASSAYED ALCOHOL/AMMONIA CONTROL LEVEL 1 AND 2
K951057 · Medical Analysis Systems, Inc. · Apr 1995