Cleared Abbreviated

K033380 - BAYER SPECIAL CHEMISTRY CALIBRATORS

K033380 is the FDA 510(k) clearance for BAYER SPECIAL CHEMISTRY CALIBRATORS by Bayer Diagnostics Corp.. It is a Class 2 Chemistry device (product code JIX) cleared through the Abbreviated 510(k) pathway after a 55-day FDA review.

K033380 · Bayer Diagnostics Corp. · Chemistry device
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Dec 2003
Decision
55d
Days
Class 2
Risk

K033380 is an FDA 510(k) clearance for the BAYER SPECIAL CHEMISTRY CALIBRATORS. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Bayer Diagnostics Corp. (Tarrytown, US). The FDA issued a Cleared decision on December 16, 2003 after a review of 55 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 Diagnostics Corp. devices

Submission Details

510(k) Number K033380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2003
Decision Date December 16, 2003
Days to Decision 55 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
33d faster than avg
Panel avg: 88d · This submission: 55d
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 K033380.
BAYER SPECIFIC PROTEIN REFERENCE SERUM
K033791 · Bayer Healthcare, LLC · Feb 2004
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OLYMPUS LYOPHILIZED CALIBRATOR, MODELS DR0070 AND DR0071
K032665 · Olympus America, Inc. · Nov 2003
MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS)
K033501 · Roche Diagnostics Corp. · Nov 2003
MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2
K032287 · Beckman Coulter, Inc. · Aug 2003