Cleared Abbreviated

K030169 - SETPOINT CHEMISTRY CALIBRATOR

K030169 is an FDA 510(k) clearance for SETPOINT CHEMISTRY 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 14-day FDA review.

K030169 · Bayer Healthcare, LLC · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
14d
Days
Class 2
Risk

K030169 is an FDA 510(k) clearance for the SETPOINT CHEMISTRY 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 January 31, 2003 after a review of 14 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 - K030169

510(k) Number K030169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2003
Decision Date January 31, 2003
Days to Decision 14 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
74d faster than avg
Panel avg: 88d · This submission: 14d
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 K030169.
LIPOPROTEIN CALIBRATOR
K031682 · Bayer Healthcare, LLC · Jun 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
LINICAL IMMUNOLOGY CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS
K030074 · Cliniqa Corporation · Jan 2003
VITROS CHEMISTRY PRODUCTS MG SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
K023876 · Ortho-Clinical Diagnostics, Inc. · Dec 2002
PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS
K023268 · Phoenix Diagnostics, Inc. · Nov 2002