Cleared Abbreviated

K031682 - LIPOPROTEIN CALIBRATOR

K031682 is an FDA 510(k) clearance for LIPOPROTEIN CALIBRATOR, manufactured by Bayer Healthcare, LLC. The device is a Class 2 Chemistry device with product code JIX cleared through the Abbreviated 510(k) pathway after a 26-day FDA review.

K031682 · Bayer Healthcare, LLC · Chemistry device
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Jun 2003
Decision
26d
Days
Class 2
Risk

K031682 is an FDA 510(k) clearance for the LIPOPROTEIN CALIBRATOR. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Bayer Healthcare, LLC (Tarrytown, US). The FDA issued a Cleared decision on June 25, 2003 after a review of 26 days - a notably fast clearance 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 Bayer Healthcare, LLC devices

FDA 510(k) Submission Details - K031682

510(k) Number K031682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2003
Decision Date June 25, 2003
Days to Decision 26 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 88d · This submission: 26d
Pathway characteristics
Standards-based clearance path.

JIX Device Classification - Class 2, Special Controls

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 252
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K031682.
RANDOX LIQUID PROTEIN CALIBRATOR
K031608 · Randox Laboratories, Ltd. · Aug 2003
TOX AMMONIA CALIBRATOR
K031683 · Bayer Healthcare, LLC · Aug 2003
AMMONIA/ETHANOL/CO2 CALIBRATOR, CONTROL NORMAL, CONTROL ABNORMAL
K031880 · Roche Diagnostics Corp. · Jul 2003
BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR
K030804 · Bayer Healthcare, LLC · Apr 2003
WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006
K024305 · Wiener Laboratories Saic · Mar 2003
SETPOINT CHEMISTRY CALIBRATOR
K030169 · Bayer Healthcare, LLC · Jan 2003