Cleared Special

K030626 - VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 7

K030626 is an FDA 510(k) clearance for VITROS CHEMISTRY PRODUCTS CRP SLIDE AND..., manufactured by Ortho-Clinical Diagnostics, Inc.. The device is a Class 2 Immunology device with product code DCK cleared through the Special 510(k) pathway after a 19-day FDA review.

K030626 · Ortho-Clinical Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
19d
Days
Class 2
Risk

K030626 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 7. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on March 18, 2003 after a review of 19 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 - K030626

510(k) Number K030626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2003
Decision Date March 18, 2003
Days to Decision 19 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
86d faster than avg
Panel avg: 105d · This submission: 19d
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 125
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K030626.
EXTENDED RANGE HS CRP KIT, CAT NO:9200
K030044 · Reference Diagnostics, Inc. · Sep 2003
WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET
K024280 · Wako Chemicals USA, Inc. · Jun 2003
CRP-LATEX (II)X2 SEIKEN ASSAY KIT
K030545 · Denka Seiken Co., Ltd. · Jun 2003
K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR
K023828 · Kamiya Biomedical Co. · Feb 2003
HEMOSIL C-REACTIVE PROTEIN - HIGH SENSITIVITY AND HIGH SENSITIVITY CONTROLS
K023269 · Instrumentation Laboratory CO · Dec 2002
ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257
K022176 · Orion Diagnostica, Div. Orion Corp. · Dec 2002
K030626 · VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 7
Download PDF FDA Summary Ortho-Clinical Diagno…