Cleared Traditional

K040241 - N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET

K040241 is an FDA 510(k) clearance for N-GENEOUS WIDE RANGE CRP REAGENT AND CA..., manufactured by Genzyme Corp.. The device is a Class 2 Chemistry device with product code DCK cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K040241 · Genzyme Corp. · Chemistry device
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Jun 2004
Decision
143d
Days
Class 2
Risk

K040241 is an FDA 510(k) clearance for the N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Genzyme Corp. (Cambridge, US). The FDA issued a Cleared decision on June 25, 2004 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5270 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Genzyme Corp. devices

FDA 510(k) Submission Details - K040241

510(k) Number K040241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2004
Decision Date June 25, 2004
Days to Decision 143 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 88d · This submission: 143d
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 Chemistry devices follow this clearance model.

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

All 105
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K040241.
CRP DIAGNOSTIC ASSAY
K050836 · Sentinel Ch. Srl · Aug 2005
WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY
K041155 · Stanbio Laboratory · Oct 2004
QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085
K042442 · Orion Diagnostica, OY · Sep 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
EXTENDED RANGE HS CRP KIT, CAT NO:9200
K030044 · Reference Diagnostics, Inc. · Sep 2003