Cleared Traditional

Diazyme EZ Vitamin D Assay (K172992) - FDA 510(k) Clearance

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

K172992 · Diazyme Laboratories · Chemistry device
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Jan 2018
Decision
106d
Days
Class 2
Risk

K172992 is an FDA 510(k) clearance for the Diazyme EZ Vitamin D Assay. Classified as System, Test, Vitamin D (product code MRG), Class II - Special Controls.

Submitted by Diazyme Laboratories (Poway, US). The FDA issued a Cleared decision on January 11, 2018 after a review of 106 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 Diazyme Laboratories devices

Submission Details

510(k) Number K172992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2017
Decision Date January 11, 2018
Days to Decision 106 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 88d · This submission: 106d
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 16
Devices cleared under the same product code (MRG) and FDA review panel - the closest regulatory comparables to K172992.
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
BioPlex 2200 25-OH Vitamin D Kit
K180577 · Bio-Rad Laboratories · Jun 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