Cleared Abbreviated

K133676 - ABX PENTRA MICRO ALB CONTROL L/H (FDA 510(k) Clearance)

Class I Chemistry device.

K133676 · HORIBA ABX SAS · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
224d
Days
Class 1
Risk

K133676 is an FDA 510(k) clearance for the ABX PENTRA MICRO ALB CONTROL L/H. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by HORIBA ABX SAS (Montpellier, FR). The FDA issued a Cleared decision on July 11, 2014 after a review of 224 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 K133676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2013
Decision Date July 11, 2014
Days to Decision 224 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
136d slower than avg
Panel avg: 88d · This submission: 224d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.