Cleared Special

K023875 - VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4

K023875 is an FDA 510(k) clearance for VITROS CHEMISTRY PRODUCTS ALB SLIDE, manufactured by Ortho-Clinical Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code CIX cleared through the Special 510(k) pathway after a 19-day FDA review.

K023875 · Ortho-Clinical Diagnostics, Inc. · Chemistry 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

K023875 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4. Classified as Bromcresol Green Dye-binding, Albumin (product code CIX), 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 Chemistry FDA review panel, regulated under 21 CFR 862.1035 - the FDA in vitro diagnostics and chemistry 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 - K023875

510(k) Number K023875 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 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
70d faster than avg
Panel avg: 89d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

CIX Device Classification - Class 2, Special Controls

Product Code CIX Bromcresol Green Dye-binding, Albumin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1035
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 - CIX Bromcresol Green Dye-binding, Albumin

All 117
Devices cleared under the same product code (CIX) and FDA review panel - the closest regulatory comparables to K023875.
ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL
K060434 · Horiba Abx · Jun 2007
ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2
K033009 · Roche Diagnostics Corp. · Oct 2003
ATAC PAK ALBUMIN REAGENT
K030006 · Elan Diagnostics · Mar 2003
PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & MEDICAL ANALYSIS SYSTEMS REAGENTS
K022072 · Precision Systems, Inc. · Aug 2002
WIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 ML CAT 1009300
K012329 · Wiener Laboratories Saic · Sep 2001
OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER
K011720 · Olympus America, Inc. · Jun 2001
K023875 · VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4
Download PDF FDA Summary Ortho-Clinical Diagno…