Cleared Traditional

K140554 - IDS-ISYS 25-HYDROXY VITAMIN DS

K140554 is the FDA 510(k) clearance for IDS-ISYS 25-HYDROXY VITAMIN DS by Immunodiagnostic Systems , Ltd.. It is a Class 2 Chemistry device (product code MRG) cleared through the Traditional 510(k) pathway after a 290-day FDA review.

K140554 · Immunodiagnostic Systems , Ltd. · Chemistry device
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Optimized for regulatory review, auditing and printing
Dec 2014
Decision
290d
Days
Class 2
Risk

K140554 is an FDA 510(k) clearance for the IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SET. Classified as System, Test, Vitamin D (product code MRG), Class II - Special Controls.

Submitted by Immunodiagnostic Systems , Ltd. (Boldon, Tyne & Wear, GB). The FDA issued a Cleared decision on December 19, 2014 after a review of 290 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 Immunodiagnostic Systems , Ltd. devices

Submission Details

510(k) Number K140554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2014
Decision Date December 19, 2014
Days to Decision 290 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
202d slower than avg
Panel avg: 88d · This submission: 290d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 29
Devices cleared under the same product code (MRG) and FDA review panel - the closest regulatory comparables to K140554.
Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators
K153361 · Fujirebio Diagnostics,Inc. · Apr 2016
BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D CALIBRATOR SET, AND BIOPLEX(R) 2200 25-OH VITAMIN D
K141114 · Bio-Rad Laboratories · Jan 2015
Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access 25(OH) Vitamin D Total Calibrators for Use on the Access 2 Immuno. Syst
K142373 · Beckman Coulter, Inc. · Dec 2014
Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(OH) Vitamin D Total Calibrators for Use on the UniCel Dxl Immuno.
K142362 · Beckman Coulter, Inc. · Dec 2014
LIASON XL1,25 DIHYDROXYVITAMIN D
K141463 · DiaSorin, Inc. · Dec 2014
ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY
K133156 · Siemens Healthcare Diagnostics, Inc. · Jul 2014