Cleared Special

K023893 - ST AIA-PACK CEA ENZYME IMMUNOASSAY

K023893 is an FDA 510(k) clearance for ST AIA-PACK CEA ENZYME IMMUNOASSAY, manufactured by Tosoh Medics, Inc.. The device is a Class 2 Immunology device with product code DHX cleared through the Special 510(k) pathway after a 26-day FDA review.

K023893 · Tosoh Medics, Inc. · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
26d
Days
Class 2
Risk

K023893 is an FDA 510(k) clearance for the ST AIA-PACK CEA ENZYME IMMUNOASSAY. Classified as System, Test, Carcinoembryonic Antigen (product code DHX), Class II - Special Controls.

Submitted by Tosoh Medics, Inc. (South San Francisco, US). The FDA issued a Cleared decision on December 18, 2002 after a review of 26 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 - K023893

510(k) Number K023893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2002
Decision Date December 18, 2002
Days to Decision 26 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
79d faster than avg
Panel avg: 105d · This submission: 26d
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 27
Devices cleared under the same product code (DHX) and FDA review panel - the closest regulatory comparables to K023893.
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
ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS
K031270 · Beckman Coulter, Inc. · May 2003
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
MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206
K991707 · Beckman · Jun 1999
K023893 · ST AIA-PACK CEA ENZYME IMMUNOASSAY
Download PDF FDA Summary Tosoh Medics, Inc.