Cleared Traditional

K112725 - LIAISON 25 OH VITAMIN D TOTAL ASSAY

K112725 is the FDA 510(k) clearance for LIAISON 25 OH VITAMIN D TOTAL ASSAY by DiaSorin, Inc.. It is a Class 2 Chemistry device (product code MRG) cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K112725 · DiaSorin, Inc. · Chemistry device
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Jan 2012
Decision
122d
Days
Class 2
Risk

K112725 is an FDA 510(k) clearance for the LIAISON 25 OH VITAMIN D TOTAL ASSAY. Classified as System, Test, Vitamin D (product code MRG), Class II - Special Controls.

Submitted by DiaSorin, Inc. (Baldwin, US). The FDA issued a Cleared decision on January 20, 2012 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1825 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all DiaSorin, Inc. devices

Submission Details

510(k) Number K112725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2011
Decision Date January 20, 2012
Days to Decision 122 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 88d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MRG System, Test, Vitamin D
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1825
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 Chemistry devices follow this clearance model.

Regulatory Peers - MRG System, Test, Vitamin D

All 24
Devices cleared under the same product code (MRG) and FDA review panel - the closest regulatory comparables to K112725.
LIAISON 25 TOTAL-D
K132492 · DiaSorin, Inc. · Sep 2013
VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORS
K121608 · Ortho-Clinical Diagnostics, Inc. · Feb 2013
ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5
K113546 · Roche Diagnostics · Jul 2012
ADVIA CENTAUR VITAMIN D TOTAL ASSAY
K110586 · Siemens Healthcare Diagnostics, Inc. · Oct 2011
LIAISON 25 OH VITAMIN D TOTAL
K071480 · DiaSorin, Inc. · Oct 2007
LIAISON 25 OH VITAMIN D
K032844 · DiaSorin, Inc. · Feb 2004