Cleared Special

K072794 - IMMULITE 2500 OM-MA, MODEL L5KOP

K072794 is an FDA 510(k) clearance for IMMULITE 2500 OM-MA, manufactured by Siemens Medical Solutions Diagnostics. The device is a Class 2 Immunology device with product code LTK cleared through the Special 510(k) pathway after a 35-day FDA review.

K072794 · Siemens Medical Solutions Diagnostics · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
35d
Days
Class 2
Risk

K072794 is an FDA 510(k) clearance for the IMMULITE 2500 OM-MA, MODEL L5KOP. Classified as Test, Epithelial Ovarian Tumor-associated Antigen (ca125) (product code LTK), Class II - Special Controls.

Submitted by Siemens Medical Solutions Diagnostics (Los Angeles, US). The FDA issued a Cleared decision on November 5, 2007 after a review of 35 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 - K072794

510(k) Number K072794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2007
Decision Date November 05, 2007
Days to Decision 35 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
70d faster than avg
Panel avg: 105d · This submission: 35d
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 K072794.
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
VIDAS CA 125 II ASSAY
K080561 · bioMerieux, Inc. · Apr 2009
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
K072794 · IMMULITE 2500 OM-MA, MODEL L5KOP
Download PDF FDA Summary Siemens Medical Solut…