Cleared Traditional

K162754 - FREND Vitamin D Test System

K162754 is the FDA 510(k) clearance for FREND Vitamin D Test System by Nanoentek USA, Inc.. It is a Class 2 Chemistry device (product code MRG) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K162754 · Nanoentek USA, Inc. · Chemistry device
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Jan 2017
Decision
104d
Days
Class 2
Risk

K162754 is an FDA 510(k) clearance for the FREND Vitamin D Test System. Classified as System, Test, Vitamin D (product code MRG), Class II - Special Controls.

Submitted by Nanoentek USA, Inc. (Pleasanton, US). The FDA issued a Cleared decision on January 12, 2017 after a review of 104 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 Nanoentek USA, Inc. devices

Submission Details

510(k) Number K162754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2016
Decision Date January 12, 2017
Days to Decision 104 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
16d slower than avg
Panel avg: 88d · This submission: 104d
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 K162754.
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
Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5
K162840 · Roche Diagnostics · Feb 2017
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
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