Cleared Traditional

K032844 - LIAISON 25 OH VITAMIN D

K032844 is the FDA 510(k) clearance for LIAISON 25 OH VITAMIN D by DiaSorin, Inc.. It is a Class 2 Chemistry device (product code MRG) cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K032844 · DiaSorin, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
154d
Days
Class 2
Risk

K032844 is an FDA 510(k) clearance for the LIAISON 25 OH VITAMIN 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 February 12, 2004 after a review of 154 days - an extended review 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: 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 K032844 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2003
Decision Date February 12, 2004
Days to Decision 154 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
66d slower than avg
Panel avg: 88d · This submission: 154d
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 28
Devices cleared under the same product code (MRG) and FDA review panel - the closest regulatory comparables to K032844.
ADVIA CENTAUR VITAMIN D TOTAL ASSAY
K110586 · Siemens Healthcare Diagnostics, Inc. · Oct 2011
DIAZYME 25-HYDROXY VITAMIN D ASSAY KIT MODEL DZ688A, DIAZYME 25-HYDROXY VITAMIN D ASSAY CALIBRATOR SET MODEL DZ688A-CAL,
K102432 · Diazyme Laboratories · Jan 2011
LIAISON 25 OH VITAMIN D TOTAL
K071480 · DiaSorin, Inc. · Oct 2007
1,25-DIHYDROXYVITAMIN D125I RIA
K014030 · DiaSorin, Inc. · Mar 2002
INCSTAR 25-HYDROXYVITMIN D 1251 RIA
K953567 · Incstar Corp. · Sep 1996