Cleared Special

K152433 - VITROS Chemistry Products CRP Slides

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

K152433 is an FDA 510(k) clearance for VITROS Chemistry Products CRP Slides, manufactured by Ortho-Clinical Diagnostics. The device is a Class 2 Immunology device with 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) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K152433

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 105d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

DCK Device Classification - Class 2, Special Controls

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 115
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K152433.
Yumizen C1200 CRP
K191993 · HORIBA ABX SAS · Oct 2019
VITROS Chemistry Products hsCRP Reagent
K160712 · Ortho-Clinical Diagnostics · Jul 2017
QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument
K142993 · Orion Diagnostica, OY · Mar 2016
FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator Kit, FastPack High Sensitivity C-Reactive Protein Controls, FastPack High Sensitivity C-Reactive Protein Method Verification Kit
K141689 · Qualigen, Inc. · Jan 2015
DIAZYME HSCRP POC TEST KIT
K121558 · Diazyme Laboratories · Sep 2012
DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET
K103557 · Diazyme Laboratories · Apr 2011
K152433 · VITROS Chemistry Products CRP Slides
Download PDF FDA Summary Ortho-Clinical Diagno…