Cleared Traditional

K122420 - DIAZYME 25-HYDROXY VITAMIN D EIA KIT DI...

K122420 is an FDA 510(k) clearance for DIAZYME 25-HYDROXY VITAMIN D EIA KIT DI..., manufactured by Diazyme Laboratories. The device is a Class 2 Chemistry device with product code MRG cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K122420 · Diazyme Laboratories · Chemistry device
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Nov 2012
Decision
111d
Days
Class 2
Risk

K122420 is an FDA 510(k) clearance for the DIAZYME 25-HYDROXY VITAMIN D EIA KIT DIAZYME 25-HYDROXY VITAMIN D EIA CONTROL.... Classified as System, Test, Vitamin D (product code MRG), Class II - Special Controls.

Submitted by Diazyme Laboratories (Poway, US). The FDA issued a Cleared decision on November 28, 2012 after a review of 111 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 Diazyme Laboratories devices

FDA 510(k) Submission Details - K122420

510(k) Number K122420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2012
Decision Date November 28, 2012
Days to Decision 111 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
23d slower than avg
Panel avg: 88d · This submission: 111d
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 39
Devices cleared under the same product code (MRG) and FDA review panel - the closest regulatory comparables to K122420.
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
ST AIA-PACK 25-OH VITAMIN D, ST AIA-PACK 25-OH VITAMIN D CALIBRATOR SET, AIA-PACK 25-OH VITAMIN D CONTROL SET, AND ST AI
K123131 · Tosoh Bioscience, 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
ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS
K110619 · Biokit, S.A. · Nov 2011