Cleared Traditional

K022329 - CA 125 II ASSAY FOR THE BAYER ADVIA INT...

K022329 is the FDA 510(k) clearance for CA 125 II ASSAY FOR THE BAYER ADVIA INT... by Bayer Diagnostics Corp.. It is a Class 2 Immunology device (product code LTK) cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K022329 · Bayer Diagnostics Corp. · Immunology device
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Nov 2002
Decision
132d
Days
Class 2
Risk

K022329 is an FDA 510(k) clearance for the CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM. Classified as Test, Epithelial Ovarian Tumor-associated Antigen (ca125) (product code LTK), Class II - Special Controls.

Submitted by Bayer Diagnostics Corp. (Tarrytown, US). The FDA issued a Cleared decision on November 27, 2002 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.6010 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bayer Diagnostics Corp. devices

Submission Details

510(k) Number K022329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2002
Decision Date November 27, 2002
Days to Decision 132 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 104d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 22
Devices cleared under the same product code (LTK) and FDA review panel - the closest regulatory comparables to K022329.
ACCESS OV MONITOR ASSAY
K031297 · Beckman Coulter, Inc. · May 2003
ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY
K023597 · Beckman Coulter, Inc. · Dec 2002
ST AIA-PACK CA 125 ENZYME IMMUNOASSAY
K023891 · Tosoh Medics, 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