Cleared Abbreviated

K071779 - ABX PENTRA URINE CAL

K071779 is the FDA 510(k) clearance for ABX PENTRA URINE CAL by Horiba Abx. It is a Class 2 Chemistry device (product code JIX) cleared through the Abbreviated 510(k) pathway after a 247-day FDA review.

K071779 · Horiba Abx · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
247d
Days
Class 2
Risk

K071779 is an FDA 510(k) clearance for the ABX PENTRA URINE CAL. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Horiba Abx (Montpellier, FR). The FDA issued a Cleared decision on March 5, 2008 after a review of 247 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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 devices

Submission Details

510(k) Number K071779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2007
Decision Date March 05, 2008
Days to Decision 247 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
159d slower than avg
Panel avg: 88d · This submission: 247d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code JIX Calibrator, Multi-analyte Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIX Calibrator, Multi-analyte Mixture

All 202
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K071779.
DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360
K083579 · Siemens Healthcare Diagnostics · Feb 2009
LOCI THYROID CALIBRATOR WITH MODEL RC610
K081103 · Siemens Healthcare Diagnostics, Inc. · May 2008
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160
K080607 · Roche Diagnostics Corp. · May 2008
DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL H
K072435 · Dade Behring, Inc. · Oct 2007
VITROS CHEMISTRY PRODUCTS CI-SLIDES, CALIBRATOR KIT 2, MODEL(S) 844-5207, 166-2659
K071801 · Ortho-Clinical Diagnostics, Inc. · Jul 2007
MULTI-ANALYTE CHEMISTRY CALIBRATOR
K070207 · Pointe Scientific, Inc., · Apr 2007