Cleared Traditional

K990431 - AIA-PACK CA 125

K990431 is an FDA 510(k) clearance for AIA-PACK CA 125, manufactured by Tosoh Medics, Inc.. The device is a Class 2 Immunology device with product code LTK cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K990431 · Tosoh Medics, Inc. · Immunology device
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Jun 1999
Decision
112d
Days
Class 2
Risk

K990431 is an FDA 510(k) clearance for the AIA-PACK CA 125. 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 June 3, 1999 after a review of 112 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 Tosoh Medics, Inc. devices

FDA 510(k) Submission Details - K990431

510(k) Number K990431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1999
Decision Date June 03, 1999
Days to Decision 112 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 105d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LTK Device Classification - Class 2, Special Controls

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 23
Devices cleared under the same product code (LTK) and FDA review panel - the closest regulatory comparables to K990431.
ST AIA-PACK CA 125 ENZYME IMMUNOASSAY
K023891 · Tosoh Medics, Inc. · Dec 2002
CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
K022329 · Bayer Diagnostics Corp. · Nov 2002
CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM
K020828 · Bayer Corp. · Jul 2002
THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
K983715 · Bayer Corp. · May 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II REAGENT PACK
K983875 · Ortho-Clinical Diagnostics, Inc. · May 1999
IMMULITE 2000 OM-MA MODEL L2KOP2
K983391 · Diagnostic Products Corp. · Oct 1998