Cleared Traditional

K110619 - ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS

K110619 is an FDA 510(k) clearance for ARCHITECT 25-OH VITAMIN D 100T, manufactured by Biokit, S.A.. The device is a Class 2 Chemistry device with product code MRG cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K110619 · Biokit, S.A. · Chemistry device
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Nov 2011
Decision
265d
Days
Class 2
Risk

K110619 is an FDA 510(k) clearance for the ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMI.... Classified as System, Test, Vitamin D (product code MRG), Class II - Special Controls.

Submitted by Biokit, S.A. (Llissa D'Amunt, Barcelona, ES). The FDA issued a Cleared decision on November 23, 2011 after a review of 265 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 Biokit, S.A. devices

FDA 510(k) Submission Details - K110619

510(k) Number K110619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2011
Decision Date November 23, 2011
Days to Decision 265 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
177d slower than avg
Panel avg: 88d · This submission: 265d
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 K110619.
DIAZYME 25-HYDROXY VITAMIN D EIA KIT DIAZYME 25-HYDROXY VITAMIN D EIA CONTROL SET DIA
K122420 · Diazyme Laboratories · Nov 2012
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
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