Cleared Traditional

K052591 - NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT

K052591 is an FDA 510(k) clearance for NANOPIA WIDE RANGE C-REACTIVE PROTEIN (..., manufactured by Clinical Data, Inc.. The device is a Class 2 Chemistry device with product code DCK cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K052591 · Clinical Data, Inc. · Chemistry device
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Feb 2006
Decision
141d
Days
Class 2
Risk

K052591 is an FDA 510(k) clearance for the NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Clinical Data, Inc. (Newton, US). The FDA issued a Cleared decision on February 9, 2006 after a review of 141 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 Clinical Data, Inc. devices

FDA 510(k) Submission Details - K052591

510(k) Number K052591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2005
Decision Date February 09, 2006
Days to Decision 141 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
53d slower than avg
Panel avg: 88d · This submission: 141d
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 100
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K052591.
DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET
K103557 · Diazyme Laboratories · Apr 2011
ABX PENTRA 400 : CRP
K061138 · Horiba Abx · Sep 2006
CRP-ADVANCE ASSAY, MODELS 250-20, 250-25
K060139 · Diagnostic Chemicals , Ltd. · Apr 2006
WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY
K041155 · Stanbio Laboratory · Oct 2004
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