Cleared Special

K023876 - VITROS CHEMISTRY PRODUCTS MG SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1

K023876 is an FDA 510(k) clearance for VITROS CHEMISTRY PRODUCTS MG SLIDE, manufactured by Ortho-Clinical Diagnostics, Inc.. The device is a Class 2 Toxicology device with product code JIX cleared through the Special 510(k) pathway after a 19-day FDA review.

K023876 · Ortho-Clinical Diagnostics, Inc. · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
19d
Days
Class 2
Risk

K023876 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS MG SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on December 10, 2002 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1150 - the FDA toxicology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K023876

510(k) Number K023876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2002
Decision Date December 10, 2002
Days to Decision 19 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 87d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

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 Toxicology devices follow this clearance model.

Regulatory Peers - JIX Calibrator, Multi-analyte Mixture

All 301
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K023876.
CALIBRATION PACK, MODELS A9100-101S AND A9100-103S
K023792 · Thermo Orion · Jan 2003
SETPOINT CHEMISTRY CALIBRATOR
K030169 · Bayer Healthcare, LLC · Jan 2003
LINICAL IMMUNOLOGY CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS
K030074 · Cliniqa Corporation · Jan 2003
PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS
K023268 · Phoenix Diagnostics, Inc. · Nov 2002
RANDOX APOLIPOPROTEIN CALIBRATOR
K023158 · Randox Laboratories, Ltd. · Oct 2002
RAICHEM LIPID CALIBRATOR
K022767 · Hemagen Diagnostics, Inc. · Sep 2002
K023876 · VITROS CHEMISTRY PRODUCTS MG SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
Download PDF FDA Summary Ortho-Clinical Diagno…