Cleared Special

VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS (K041322) - FDA 510(k) Clearance

Class II Immunology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K041322 · Ortho-Clinical Diagnostics, Inc. · Immunology device
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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.

View all Ortho-Clinical Diagnostics, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 104d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 27
Devices cleared under the same product code (DHX) and FDA review panel - the closest regulatory comparables to K041322.
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K200215 · Siemens Healthcare Disgnostics, Inc. · Apr 2020
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