Cleared Abbreviated

K123171 - ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT (FDA 510(k) Clearance)

Class II Chemistry device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K123171 · HORIBA ABX SAS · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
267d
Days
Class 2
Risk

K123171 is an FDA 510(k) clearance for the ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, .... Classified as Azo Dye, Calcium (product code CJY), Class II - Special Controls.

Submitted by HORIBA ABX SAS (Montpellier, FR). The FDA issued a Cleared decision on July 3, 2013 after a review of 267 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1145 - the FDA in vitro diagnostics and chemistry framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all HORIBA ABX SAS devices

Submission Details

510(k) Number K123171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2012
Decision Date July 03, 2013
Days to Decision 267 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
179d slower than avg
Panel avg: 88d · This submission: 267d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code CJY Azo Dye, Calcium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1145
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.