Cleared Traditional

K123364 - 25OH VITAMIN D TOTAL ELISA TEST

K123364 is an FDA 510(k) clearance for 25OH VITAMIN D TOTAL ELISA TEST, manufactured by Diasource Immunoassays, S.A.. The device is a Class 2 Chemistry device with product code MRG cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K123364 · Diasource Immunoassays, S.A. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
256d
Days
Class 2
Risk

K123364 is an FDA 510(k) clearance for the 25OH VITAMIN D TOTAL ELISA TEST. Classified as System, Test, Vitamin D (product code MRG), Class II - Special Controls.

Submitted by Diasource Immunoassays, S.A. (Davis, US). The FDA issued a Cleared decision on July 15, 2013 after a review of 256 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 Diasource Immunoassays, S.A. devices

FDA 510(k) Submission Details - K123364

510(k) Number K123364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2012
Decision Date July 15, 2013
Days to Decision 256 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
168d slower than avg
Panel avg: 88d · This submission: 256d
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 44
Devices cleared under the same product code (MRG) and FDA review panel - the closest regulatory comparables to K123364.
DIAZYME 25-OH VITAMIN D ASSAY
K133410 · Diazyme Laboratories · Mar 2014
LIAISON 25 TOTAL-D
K132492 · DiaSorin, Inc. · Sep 2013
25-OH VITAMIN D ELISA
K123660 · Euroimmun US · Jul 2013
FASTPACK VITAMIN D
K123983 · Qualigen, Inc. · Jul 2013
IDS ISYS 1,25 DIHYDROXY VITAMIN D, IDS-ISYS, 1,25 DIHYDROXY VITAMIN D CONTROL SET, AND IDS ISYS 1,25 DIHYDROXY VITAMIN D
K123253 · Immunodiagnostic Systems , Ltd. · Jun 2013
VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORS
K121608 · Ortho-Clinical Diagnostics, Inc. · Feb 2013