Cleared Special

K023894 - ST AIA-PACK AFP ENZYME IMMUNOASSAY

K023894 is an FDA 510(k) clearance for ST AIA-PACK AFP ENZYME IMMUNOASSAY, manufactured by Tosoh Medics, Inc.. The device is a Class 2 Immunology device with product code LOJ cleared through the Special 510(k) pathway after a 25-day FDA review.

K023894 · 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
25d
Days
Class 2
Risk

K023894 is an FDA 510(k) clearance for the ST AIA-PACK AFP ENZYME IMMUNOASSAY. Classified as Kit, Test,alpha-fetoprotein For Testicular Cancer (product code LOJ), Class II - Special Controls.

Submitted by Tosoh Medics, Inc. (South San Francisco, US). The FDA issued a Cleared decision on December 17, 2002 after a review of 25 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 - K023894

510(k) Number K023894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2002
Decision Date December 17, 2002
Days to Decision 25 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
80d faster than avg
Panel avg: 105d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

LOJ Device Classification - Class 2, Special Controls

Product Code LOJ Kit, Test,alpha-fetoprotein For Testicular Cancer
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 - LOJ Kit, Test,alpha-fetoprotein For Testicular Cancer

All 16
Devices cleared under the same product code (LOJ) and FDA review panel - the closest regulatory comparables to K023894.
OLYMPUS AFP - ALPHA-FETOPROTEIN
K081709 · Olympus Life Science Research Europa GmbH (Europa) · Mar 2009
VIDAS AFP ASSAY
K080017 · bioMerieux, Inc. · Sep 2008
DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600
K071597 · Dade Behring, Inc. · Jun 2008
AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K020807 · Bayer Diagnostics Corp. · Oct 2002
ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY
K020806 · Bayer Corp. · Mar 2002
DSL ACTIVE AFP ELISA, MODEL DSL-10-8400
K990138 · Diagnostic Systems Laboratories, Inc. · Jun 1999
K023894 · ST AIA-PACK AFP ENZYME IMMUNOASSAY
Download PDF FDA Summary Tosoh Medics, Inc.