Cleared Traditional

K100321 - DIMENSION VISTA LOCI CA 125 FLEX REAGEN...

K100321 is an FDA 510(k) clearance for DIMENSION VISTA LOCI CA 125 FLEX REAGEN..., manufactured by Siemens Healthcare Diagnostics. The device is a Class 2 Immunology device with product code LTK cleared through the Traditional 510(k) pathway after a 432-day FDA review.

K100321 · Siemens Healthcare Diagnostics · Immunology device
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Optimized for regulatory review, auditing and printing
Apr 2011
Decision
432d
Days
Class 2
Risk

K100321 is an FDA 510(k) clearance for the DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI .... Classified as Test, Epithelial Ovarian Tumor-associated Antigen (ca125) (product code LTK), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on April 12, 2011 after a review of 432 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Immunology submissions.

View all Siemens Healthcare Diagnostics devices

FDA 510(k) Submission Details - K100321

510(k) Number K100321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2010
Decision Date April 12, 2011
Days to Decision 432 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
328d slower than avg
Panel avg: 104d · This submission: 432d
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 K100321.
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
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