Cleared Traditional

ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5 (K113546) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K113546 · Roche Diagnostics · Chemistry device
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Jul 2012
Decision
236d
Days
Class 2
Risk

K113546 is an FDA 510(k) clearance for the ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3.... 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 July 24, 2012 after a review of 236 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.

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Submission Details

510(k) Number K113546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2011
Decision Date July 24, 2012
Days to Decision 236 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
148d slower than avg
Panel avg: 88d · This submission: 236d
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 45
Devices cleared under the same product code (MRG) and FDA review panel - the closest regulatory comparables to K113546.
MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer
K232587 · Shenzhen New Industries Biomedical Engineering Co., Ltd. · Apr 2024
ALFIS Vitamin D, ALFIS-3 Analyzer
K221817 · Immunostics Inc., · Sep 2023
Access 25(OH) Vitamin D Total
K223503 · Beckman Coulter, Inc. · Jan 2023
Elecsys Vitamin D total III
K210901 · Roche Diagnostics · Sep 2021
ADVIA Centaur Vitamin D Total (VitD)
K200509 · Siemens Healthcare Diagnostics, Inc. · May 2020
MAGLUMI 2000 25-OH Vitamin D
K191499 · Shenzhen New Industries Biomedical Engineering Co., Ltd. · Aug 2019