Cleared Traditional

K162298 - LOCI Total Vitamin D Total Assay, LOCI VITD CAL

K162298 is an FDA 510(k) clearance for LOCI Total Vitamin D Total Assay, manufactured by Siemens Healthcare Diagnostics. The device is a Class 2 Chemistry device with product code MRG cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K162298 · Siemens Healthcare Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2017
Decision
212d
Days
Class 2
Risk

K162298 is an FDA 510(k) clearance for the LOCI Total Vitamin D Total Assay, LOCI VITD CAL. Classified as System, Test, Vitamin D (product code MRG), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on March 16, 2017 after a review of 212 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 Siemens Healthcare Diagnostics devices

FDA 510(k) Submission Details - K162298

510(k) Number K162298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2016
Decision Date March 16, 2017
Days to Decision 212 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
124d slower than avg
Panel avg: 88d · This submission: 212d
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 K162298.
MAGLUMI 2000 25-OH Vitamin D
K191499 · Shenzhen New Industries Biomedical Engineering Co., Ltd. · Aug 2019
BioPlex 2200 25-OH Vitamin D Kit
K180577 · Bio-Rad Laboratories · Jun 2018
Diazyme EZ Vitamin D Assay
K172992 · Diazyme Laboratories · Jan 2018
Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5
K162840 · Roche Diagnostics · Feb 2017
FREND Vitamin D Test System
K162754 · Nanoentek USA, Inc. · Jan 2017
IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set
K161831 · Immunodiagnostic Systems , Ltd. · Nov 2016