Cleared Traditional

K091849 - IDS-ISYS 25-HYDROXY VITAMIN D ASSAY, IDS-ISYS 25-HYDROXY VITAMIN D CONTROL SET

K091849 is an FDA 510(k) clearance for IDS-ISYS 25-HYDROXY VITAMIN D ASSAY, manufactured by Immunodiagnostic Systems, Inc.. The device is a Class 2 Chemistry device with product code MRG cleared through the Traditional 510(k) pathway after a 368-day FDA review.

K091849 · Immunodiagnostic Systems, Inc. · Chemistry device
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Jun 2010
Decision
368d
Days
Class 2
Risk

K091849 is an FDA 510(k) clearance for the IDS-ISYS 25-HYDROXY VITAMIN D ASSAY, IDS-ISYS 25-HYDROXY VITAMIN D CONTROL SET. Classified as System, Test, Vitamin D (product code MRG), Class II - Special Controls.

Submitted by Immunodiagnostic Systems, Inc. (Fountain Hills, US). The FDA issued a Cleared decision on June 25, 2010 after a review of 368 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Immunodiagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K091849

510(k) Number K091849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2009
Decision Date June 25, 2010
Days to Decision 368 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
280d slower than avg
Panel avg: 88d · This submission: 368d
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 40
Devices cleared under the same product code (MRG) and FDA review panel - the closest regulatory comparables to K091849.
ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS
K110619 · Biokit, S.A. · Nov 2011
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
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