Cleared Traditional

K133410 - DIAZYME 25-OH VITAMIN D ASSAY

Also marketed or referenced as:
DIAZYME 25-OH VITAMIN D CONTROL SET

K133410 is an FDA 510(k) clearance for DIAZYME 25-OH VITAMIN D ASSAY, manufactured by Diazyme Laboratories. The device is a Class 2 Chemistry device with product code MRG cleared through the Traditional 510(k) pathway after a 127-day FDA review.

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

FDA 510(k) Submission Details - K133410

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
Combination Product No
PCCP Authorized No
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.

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 39
Devices cleared under the same product code (MRG) and FDA review panel - the closest regulatory comparables to K133410.
Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(OH) Vitamin D Total Calibrators for Use on the UniCel Dxl Immuno.
K142362 · Beckman Coulter, Inc. · Dec 2014
LIASON XL1,25 DIHYDROXYVITAMIN D
K141463 · DiaSorin, Inc. · Dec 2014
ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY
K133156 · Siemens Healthcare Diagnostics, Inc. · Jul 2014
LIAISON 25 TOTAL-D
K132492 · DiaSorin, Inc. · Sep 2013
IDS ISYS 1,25 DIHYDROXY VITAMIN D, IDS-ISYS, 1,25 DIHYDROXY VITAMIN D CONTROL SET, AND IDS ISYS 1,25 DIHYDROXY VITAMIN D
K123253 · Immunodiagnostic Systems , Ltd. · Jun 2013
VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORS
K121608 · Ortho-Clinical Diagnostics, Inc. · Feb 2013