Cleared Traditional

K161721 - Diazyme Vitamin B12 Assay

K161721 is an FDA 510(k) clearance for Diazyme Vitamin B12 Assay, manufactured by Diazyme Laboratories. The device is a Class 2 Chemistry device with product code CDD cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K161721 · Diazyme Laboratories · Chemistry device
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Sep 2016
Decision
90d
Days
Class 2
Risk

K161721 is an FDA 510(k) clearance for the Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitam.... Classified as Radioassay, Vitamin B12 (product code CDD), Class II - Special Controls.

Submitted by Diazyme Laboratories (Poway, US). The FDA issued a Cleared decision on September 20, 2016 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1810 - 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 - K161721

510(k) Number K161721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2016
Decision Date September 20, 2016
Days to Decision 90 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
2d slower than avg
Panel avg: 88d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CDD Device Classification - Class 2, Special Controls

Product Code CDD Radioassay, Vitamin B12
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1810
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 - CDD Radioassay, Vitamin B12

All 62
Devices cleared under the same product code (CDD) and FDA review panel - the closest regulatory comparables to K161721.
DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12
K190298 · Beckman Coulter Biomedical GmbH · Oct 2019
LIAISON Vitamin B12
K192064 · DiaSorin, Inc. · Oct 2019
ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay
K172133 · Axis-Shield Diagnostics, Ltd. · Oct 2017
Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet
K151786 · Roche Diagnostics · Sep 2015
Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents
K140496 · Beckman Coulter, Inc. · Sep 2014
LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL)
K133512 · Siemens Healthcare Diagnostics · Jan 2014