Cleared Traditional

K061138 - ABX PENTRA 400 : CRP

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

K061138 · Horiba Abx · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
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.

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 Chemistry devices follow this clearance model.

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

All 82
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K061138.
VITROS Chemistry Products CRP Slides
K152433 · Ortho-Clinical Diagnostics · Sep 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
WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY
K041155 · Stanbio Laboratory · Oct 2004