Cleared Special

ST AIA-PACK CEA ENZYME IMMUNOASSAY (K023893) - FDA 510(k) Clearance

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

K023893 · Tosoh Medics, Inc. · Immunology device
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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.

View all Tosoh Medics, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 104d · This submission: 26d
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
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