Cleared Special

K023891 - ST AIA-PACK CA 125 ENZYME IMMUNOASSAY

K023891 is the FDA 510(k) clearance for ST AIA-PACK CA 125 ENZYME IMMUNOASSAY by Tosoh Medics, Inc.. It is a Class 2 Immunology device (product code LTK) cleared through the Special 510(k) pathway after a 14-day FDA review.

K023891 · Tosoh Medics, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
14d
Days
Class 2
Risk

K023891 is an FDA 510(k) clearance for the ST AIA-PACK CA 125 ENZYME IMMUNOASSAY. Classified as Test, Epithelial Ovarian Tumor-associated Antigen (ca125) (product code LTK), Class II - Special Controls.

Submitted by Tosoh Medics, Inc. (South San Francisco, US). The FDA issued a Cleared decision on December 6, 2002 after a review of 14 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 K023891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2002
Decision Date December 06, 2002
Days to Decision 14 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
90d faster than avg
Panel avg: 104d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LTK Test, Epithelial Ovarian Tumor-associated Antigen (ca125)
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 - LTK Test, Epithelial Ovarian Tumor-associated Antigen (ca125)

All 21
Devices cleared under the same product code (LTK) and FDA review panel - the closest regulatory comparables to K023891.
ARCHITECT CA 125 II ASSAY
K042731 · Fujirebio Diagnostics,Inc. · Nov 2004
ACCESS OV MONITOR ASSAY
K031297 · Beckman Coulter, Inc. · May 2003
ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY
K023597 · Beckman Coulter, Inc. · Dec 2002
CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM
K020828 · Bayer Corp. · Jul 2002
AIA-PACK CA 125
K990431 · Tosoh Medics, Inc. · Jun 1999
THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
K983715 · Bayer Corp. · May 1999