Cleared Special

K031297 - ACCESS OV MONITOR ASSAY

K031297 is an FDA 510(k) clearance for ACCESS OV MONITOR ASSAY, manufactured by Beckman Coulter, Inc.. The device is a Class 2 Immunology device with product code LTK cleared through the Special 510(k) pathway after a 8-day FDA review.

K031297 · Beckman Coulter, Inc. · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
8d
Days
Class 2
Risk

K031297 is an FDA 510(k) clearance for the ACCESS OV MONITOR ASSAY. Classified as Test, Epithelial Ovarian Tumor-associated Antigen (ca125) (product code LTK), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on May 2, 2003 after a review of 8 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 - K031297

510(k) Number K031297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2003
Decision Date May 02, 2003
Days to Decision 8 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
97d faster than avg
Panel avg: 105d · This submission: 8d
Pathway characteristics
Modification to existing cleared device.

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 25
Devices cleared under the same product code (LTK) and FDA review panel - the closest regulatory comparables to K031297.
VIDAS CA 125 II ASSAY
K080561 · bioMerieux, Inc. · Apr 2009
IMMULITE 2500 OM-MA, MODEL L5KOP
K072794 · Siemens Medical Solutions Diagnostics · Nov 2007
ARCHITECT CA 125 II ASSAY
K042731 · Fujirebio Diagnostics,Inc. · Nov 2004
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 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
K022329 · Bayer Diagnostics Corp. · Nov 2002
K031297 · ACCESS OV MONITOR ASSAY
Download PDF FDA Summary Beckman Coulter, Inc.