Cleared Traditional

K032844 - LIAISON 25 OH VITAMIN D

K032844 is an FDA 510(k) clearance for LIAISON 25 OH VITAMIN D, manufactured by DiaSorin, Inc.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K032844

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.

MRG Device Classification - Class 2, Special Controls

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 43
Devices cleared under the same product code (MRG) and FDA review panel - the closest regulatory comparables to K032844.
LIAISON 25 OH VITAMIN D TOTAL
K071480 · DiaSorin, Inc. · Oct 2007
1,25-DIHYDROXY VITAMIN D EIA
K051110 · Immunodiagnostic Systems , Ltd. · Jul 2005
GAMMA-B 1,25-DIHYDROXY VITAMIN D
K042519 · Immunodiagnostic Systems , Ltd. · Dec 2004
OCTEIA 25-HYDROXY VITAMIN D
K021163 · Immunodiagnostic Systems , Ltd. · May 2002
1,25-DIHYDROXYVITAMIN D125I RIA
K014030 · DiaSorin, Inc. · Mar 2002
GAMMA-B 25-HYDROXY VITAMIN D RIA
K991998 · Immunodiagnostic Systems , Ltd. · Sep 1999