Cleared Special

K041322 - VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS

K041322 is an FDA 510(k) clearance for VITROS IMMUNODIAGNOSTIC PRODUCTS CEA RE..., manufactured by Ortho-Clinical Diagnostics, Inc.. The device is a Class 2 Immunology device with product code DHX cleared through the Special 510(k) pathway after a 30-day FDA review.

K041322 · Ortho-Clinical Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
30d
Days
Class 2
Risk

K041322 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS. Classified as System, Test, Carcinoembryonic Antigen (product code DHX), Class II - Special Controls.

Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on June 17, 2004 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.6010 - 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 - K041322

510(k) Number K041322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2004
Decision Date June 17, 2004
Days to Decision 30 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
75d faster than avg
Panel avg: 105d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

DHX Device Classification - Class 2, Special Controls

Product Code DHX System, Test, Carcinoembryonic Antigen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6010
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 - DHX System, Test, Carcinoembryonic Antigen

All 26
Devices cleared under the same product code (DHX) and FDA review panel - the closest regulatory comparables to K041322.
OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN
K081615 · Olympus America, Inc. · Mar 2009
VIDAS CEA (S) ASSAY
K080194 · bioMerieux, Inc. · Oct 2008
DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA)
K071603 · Dade Behring, Inc. · Jun 2008
ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS
K031270 · Beckman Coulter, Inc. · May 2003
ST AIA-PACK CEA ENZYME IMMUNOASSAY
K023893 · Tosoh Medics, Inc. · Dec 2002
CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K013568 · Bayer Corp. · Dec 2001
K041322 · VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS
Download PDF FDA Summary Ortho-Clinical Diagno…