Cleared Traditional

K061138 - ABX PENTRA 400 : CRP

K061138 is an FDA 510(k) clearance for ABX PENTRA 400 : CRP, manufactured by Horiba Abx. The device is a Class 2 Chemistry device with product code DCK cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K061138 · Horiba Abx · Chemistry device
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Sep 2006
Decision
158d
Days
Class 2
Risk

K061138 is an FDA 510(k) clearance for the ABX PENTRA 400 : CRP. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Horiba Abx (Montpellier, FR). The FDA issued a Cleared decision on September 29, 2006 after a review of 158 days - an extended review cycle.

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 Horiba Abx devices

FDA 510(k) Submission Details - K061138

510(k) Number K061138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2006
Decision Date September 29, 2006
Days to Decision 158 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
70d slower than avg
Panel avg: 88d · This submission: 158d
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 K061138.
FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator Kit, FastPack High Sensitivity C-Reactive Protein Controls, FastPack High Sensitivity C-Reactive Protein Method Verification Kit
K141689 · Qualigen, Inc. · Jan 2015
DIAZYME HSCRP POC TEST KIT
K121558 · Diazyme Laboratories · Sep 2012
DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET
K103557 · Diazyme Laboratories · Apr 2011
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
CRP DIAGNOSTIC ASSAY
K050836 · Sentinel Ch. Srl · Aug 2005