Cleared Traditional

K014030 - 1,25-DIHYDROXYVITAMIN D125I RIA

K014030 is an FDA 510(k) clearance for 1, 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 110-day FDA review.

K014030 · DiaSorin, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
110d
Days
Class 2
Risk

K014030 is an FDA 510(k) clearance for the 1,25-DIHYDROXYVITAMIN D125I RIA. 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 March 26, 2002 after a review of 110 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

FDA 510(k) Submission Details - K014030

510(k) Number K014030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2001
Decision Date March 26, 2002
Days to Decision 110 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
22d slower than avg
Panel avg: 88d · This submission: 110d
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 K014030.
GAMMA-B 1,25-DIHYDROXY VITAMIN D
K042519 · Immunodiagnostic Systems , Ltd. · Dec 2004
LIAISON 25 OH VITAMIN D
K032844 · DiaSorin, Inc. · Feb 2004
OCTEIA 25-HYDROXY VITAMIN D
K021163 · Immunodiagnostic Systems , Ltd. · May 2002
GAMMA-B 25-HYDROXY VITAMIN D RIA
K991998 · Immunodiagnostic Systems , Ltd. · Sep 1999
INCSTAR 25-HYDROXYVITMIN D 1251 RIA
K953567 · Incstar Corp. · Sep 1996