Cleared Special

K152433 - VITROS Chemistry Products CRP Slides

Also marketed or referenced as:
VITRO Chemistry Products Calibrator Kit 7

K152433 is the FDA 510(k) clearance for VITROS Chemistry Products CRP Slides by Ortho-Clinical Diagnostics. It is a Class 2 Immunology device (product code DCK) cleared through the Special 510(k) pathway after a 28-day FDA review.

K152433 · Ortho-Clinical Diagnostics · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2015
Decision
28d
Days
Class 2
Risk

K152433 is an FDA 510(k) clearance for the VITROS Chemistry Products CRP Slides. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Ortho-Clinical Diagnostics (Rochester, US). The FDA issued a Cleared decision on September 24, 2015 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5270 - the FDA immunology 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.

View all Ortho-Clinical Diagnostics devices

Submission Details

510(k) Number K152433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2015
Decision Date September 24, 2015
Days to Decision 28 days
Submission Type Special
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 104d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DCK C-reactive Protein, Antigen, Antiserum, And Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5270
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 Immunology devices follow this clearance model.

Regulatory Peers - DCK C-reactive Protein, Antigen, Antiserum, And Control

All 57
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K152433.
Yumizen C1200 CRP
K192028 · HORIBA ABX SAS · Jun 2020
CRP Vario
K192118 · SENTINEL CH. SpA · Nov 2019
Yumizen C1200 CRP
K191993 · HORIBA ABX SAS · Oct 2019
QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH SENSITIVITY CONTROLS VE CONTROLS 1/2
K032663 · Instrumentation Laboratory CO · Dec 2003
WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET
K024280 · Wako Chemicals USA, Inc. · Jun 2003
VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 7
K030626 · Ortho-Clinical Diagnostics, Inc. · Mar 2003