Cleared Special

K031270 - ACCESS CEA REAGENTS FOR USE ON THE ACCE...

K031270 is the FDA 510(k) clearance for ACCESS CEA REAGENTS FOR USE ON THE ACCE... by Beckman Coulter, Inc.. It is a Class 2 Immunology device (product code DHX) cleared through the Special 510(k) pathway after a 15-day FDA review.

K031270 · Beckman Coulter, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
15d
Days
Class 2
Risk

K031270 is an FDA 510(k) clearance for the ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS. Classified as System, Test, Carcinoembryonic Antigen (product code DHX), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on May 6, 2003 after a review of 15 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 Beckman Coulter, Inc. devices

Submission Details

510(k) Number K031270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2003
Decision Date May 06, 2003
Days to Decision 15 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
89d faster than avg
Panel avg: 104d · This submission: 15d
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 18
Devices cleared under the same product code (DHX) and FDA review panel - the closest regulatory comparables to K031270.
VIDAS CEA (S) ASSAY
K080194 · bioMerieux, Inc. · Oct 2008
DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA)
K071603 · Dade Behring, Inc. · Jun 2008
VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS
K041322 · Ortho-Clinical Diagnostics, Inc. · Jun 2004
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
VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK
K990943 · Ortho-Clinical Diagnostics, Inc. · Jun 1999