Cleared Abbreviated

K110530 - ABX PENTRA CREATININE 120 CP (FDA 510(k) Clearance)

Also includes:
ABX PENTRA MULTICAL ABX PENTRA N CONTROL ABX PENTRA P CONTROL ABX PENTRA URINE CONTROL

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

K110530 · HORIBA ABX SAS · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
431d
Days
Class 2
Risk

K110530 is an FDA 510(k) clearance for the ABX PENTRA CREATININE 120 CP. Classified as Alkaline Picrate, Colorimetry, Creatinine (product code CGX), Class II - Special Controls.

Submitted by HORIBA ABX SAS (Montpellier, FR). The FDA issued a Cleared decision on April 30, 2012 after a review of 431 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1225 - 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: High-complexity regulatory submission. Standards-verified equivalence. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all HORIBA ABX SAS devices

Submission Details

510(k) Number K110530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2011
Decision Date April 30, 2012
Days to Decision 431 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
343d slower than avg
Panel avg: 88d · This submission: 431d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code CGX Alkaline Picrate, Colorimetry, Creatinine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1225
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 - CGX Alkaline Picrate, Colorimetry, Creatinine

All 158
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