Cleared Traditional

K133410 - DIAZYME 25-OH VITAMIN D ASSAY (FDA 510(k) Clearance)

Also includes:
DIAZYME 25-OH VITAMIN D CONTROL SET

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

K133410 · Diazyme Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2014
Decision
127d
Days
Class 2
Risk

K133410 is an FDA 510(k) clearance for the DIAZYME 25-OH 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 March 14, 2014 after a review of 127 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 K133410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2013
Decision Date March 14, 2014
Days to Decision 127 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
39d slower than avg
Panel avg: 88d · This submission: 127d
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 K133410.
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