Cleared Traditional

K132492 - LIAISON 25 TOTAL-D

K132492 is the FDA 510(k) clearance for LIAISON 25 TOTAL-D by DiaSorin, Inc.. It is a Class 2 Chemistry device (product code MRG) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K132492 · DiaSorin, Inc. · Chemistry device
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Sep 2013
Decision
27d
Days
Class 2
Risk

K132492 is an FDA 510(k) clearance for the LIAISON 25 TOTAL-D. Classified as System, Test, Vitamin D (product code MRG), Class II - Special Controls.

Submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Cleared decision on September 5, 2013 after a review of 27 days - a notably fast clearance cycle.

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: 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 DiaSorin, Inc. devices

Submission Details

510(k) Number K132492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2013
Decision Date September 05, 2013
Days to Decision 27 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
61d faster than avg
Panel avg: 88d · This submission: 27d
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 22
Devices cleared under the same product code (MRG) and FDA review panel - the closest regulatory comparables to K132492.
Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(OH) Vitamin D Total Calibrators for Use on the UniCel Dxl Immuno.
K142362 · Beckman Coulter, Inc. · Dec 2014
LIASON XL1,25 DIHYDROXYVITAMIN D
K141463 · DiaSorin, Inc. · Dec 2014
ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY
K133156 · Siemens Healthcare Diagnostics, Inc. · Jul 2014
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
LIAISON 25 OH VITAMIN D TOTAL ASSAY
K112725 · DiaSorin, Inc. · Jan 2012