Cleared Traditional

K162840 - Elecsys Vitamin D total II

K162840 is an FDA 510(k) clearance for Elecsys Vitamin D total II, manufactured by Roche Diagnostics. The device is a Class 2 Chemistry device with product code MRG cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K162840 · Roche Diagnostics · Chemistry device
Download Printable Device Report (PDF)
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Feb 2017
Decision
120d
Days
Class 2
Risk

K162840 is an FDA 510(k) clearance for the Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D.... Classified as System, Test, Vitamin D (product code MRG), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on February 8, 2017 after a review of 120 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 Roche Diagnostics devices

FDA 510(k) Submission Details - K162840

510(k) Number K162840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2016
Decision Date February 08, 2017
Days to Decision 120 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
32d slower than avg
Panel avg: 88d · This submission: 120d
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 K162840.
BioPlex 2200 25-OH Vitamin D Kit
K180577 · Bio-Rad Laboratories · Jun 2018
Diazyme EZ Vitamin D Assay
K172992 · Diazyme Laboratories · Jan 2018
LOCI Total Vitamin D Total Assay, LOCI VITD CAL
K162298 · Siemens Healthcare Diagnostics · Mar 2017
IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set
K161831 · Immunodiagnostic Systems , Ltd. · Nov 2016
ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls
K153375 · Abbott Laboratories · Aug 2016
Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators
K153361 · Fujirebio Diagnostics,Inc. · Apr 2016