Cleared Traditional

K240479 - Access OV Monitor

K240479 is the FDA 510(k) clearance for Access OV Monitor by Beckman Coulter, Inc.. It is a Class 2 Immunology device (product code LTK) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K240479 · Beckman Coulter, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
80d
Days
Class 2
Risk

K240479 is an FDA 510(k) clearance for the Access OV Monitor. 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 10, 2024 after a review of 80 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Beckman Coulter, Inc. devices

Submission Details

510(k) Number K240479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2024
Decision Date May 10, 2024
Days to Decision 80 days
Submission Type Traditional
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
24d faster than avg
Panel avg: 104d · This submission: 80d
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 21
Devices cleared under the same product code (LTK) and FDA review panel - the closest regulatory comparables to K240479.
IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA
K213510 · Siemens Healthcare Diagnostics Products, Ltd. · Sep 2023
VITROS Immuodiagnostic Products CA 125 II Reagent Pack
K221355 · Ortho-Clinical Diagnostics · Dec 2022
ADVIA Centaur CA 125II
K200199 · Siemens Healthcare Diagnostics, Inc. · Apr 2020
LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators
K142895 · Fujirebio Diagnostics,Inc. · May 2015
DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604
K100321 · Siemens Healthcare Diagnostics · Apr 2011
VIDAS CA 15-3 ASSAY
K080469 · bioMerieux, Inc. · Jun 2009