Cleared Traditional

K041155 - WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY

K041155 is an FDA 510(k) clearance for WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ..., manufactured by Stanbio Laboratory. The device is a Class 2 Immunology device with product code DCK cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K041155 · Stanbio Laboratory · Immunology device
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Optimized for regulatory review, auditing and printing
Oct 2004
Decision
164d
Days
Class 2
Risk

K041155 is an FDA 510(k) clearance for the WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Stanbio Laboratory (Boerne, US). The FDA issued a Cleared decision on October 14, 2004 after a review of 164 days - an extended review 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: 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 Stanbio Laboratory devices

FDA 510(k) Submission Details - K041155

510(k) Number K041155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2004
Decision Date October 14, 2004
Days to Decision 164 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 105d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DCK Device Classification - Class 2, Special Controls

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 103
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K041155.
ABX PENTRA 400 : CRP
K061138 · Horiba Abx · Sep 2006
CRP-ADVANCE ASSAY, MODELS 250-20, 250-25
K060139 · Diagnostic Chemicals , Ltd. · Apr 2006
NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT
K052591 · Clinical Data, Inc. · Feb 2006
N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET
K040241 · Genzyme Corp. · Jun 2004
CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP)
K040579 · Cholestech Corp. · Jun 2004
QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH SENSITIVITY CONTROLS VE CONTROLS 1/2
K032663 · Instrumentation Laboratory CO · Dec 2003